The American Hospital Association, an industry group, said it had reactivated a program to help distribute ventilators and supplies to regions where the Delta variant had hit hardest, according to Thomas Jordan, a spokesman. Learn About Sleep Apnea and Treatment Options, The Latest CPAP Machine Reviews from Experts, Find the Best CPAP Mask for Your Lifestyle, Our Top Picks to Make CPAP Cleaning a Breeze, Were here to help! Per Philips Respironics, products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. ResMeds guiding principles are followed by the products always prioritizing client care based on the severity of their diseases. These devices are used to provide breathing assistance. https://www.resmed.com/en-us/other-manufacturer-recall-2021/ However, if you are one of the individuals who will be receiving a device in the first wave of replacement units, you will be notified directly by Phillips and given additional information on how to complete the process. The full U.S. launch is expected in late 2021, which might receive bigger market acceptance capitalizing on its current competitive position. Doing so puts a lot of wear and tear on machines and it is completely unnecessary. These typically work best for patients with neuromuscular diseases who take smaller breaths. How do we advise our patients when we know that the potential risks are serious, but havent any idea whether they are extremely rare or just uncommon?, Dr. Schulman said the problem was the lack of clear answers: The imperfect information is affecting hundreds of each doctors patients all at once.. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Yes. Since CPAP.com does not bill insurance or accept Medicare, we are able to offer you the lowest priced machines. The longer you wait to place your order, the further down on the list youll be, and thus, the longer youll wait to get your replacement machine. US Navy Retired 1973,AirCurve 10 ASV, Mode: ASV Auto, Min EPAP: 7.2, Max EPAP: 15.0, Min PS:4.0, Max PS: 15.0, Mask ResMed AirFit P10, Backup: (2) AirCurve 10 ASV. William Blair analysts predicted that the recall would result in persistent market share increases, verging on permanent for ResMed. I stopped using both of them shortly after the recall notice went out and I went back where I purchased the Dreamstation through Medicare which was Mayo Clinic Rochester. The AirSense 10 series includes four different models: CPAP, Elite, AutoSet and AutoSet for Her Built-in humidifier and Climate Control Auto setting provide breathing comfort User-friendly controls and an intuitive interface make it simple to navigate settings and the nightly sleep report Our clinical team is here to help you. by ups4 Sun Jul 18, 2021 10:16 am, Post Now I know where the black pieces are coming from. Talk to your health care provider to decide on a suitable treatment for your condition, which may include: Using another similar device that is not part of the recall. If we dont apply sufficient humidity or if the mask does not fit properly, air may leak out of it while users sleep. We are happy to review your prescription if youre unsure of its status. Since June, about 40 lawsuits against Philips have been filed on behalf of patients in more than 20 states. I am frustrated because I was at such a wonderful place with my CPAP before the recall. We will authorize such a plan as soon as the company provides the agency with sufficient evidence to support the safe and effective mitigation of the product defect, including fixing or replacing the devices patients are currently using, she said. The ResMed AirSense 10 seems either asleep, or the electricity has been cut if the display is black and wont turn on. ResMed swoops on rival's stumble Carrie LaFrenz Senior reporter Jun 10, 2021 - 4.15pm Share ResMed is aiming to capitalise on rival Royal Philips' global device recall but is also facing. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. Service affected devices and evaluate for any evidence of foam degradation. Plus, most insurance companies require you to rent your equipment for a certain period of time and many require compliance monitoring to protect their investment. Keep in mind that the CPAP recall is an ongoing situation, so information from your health insurance provider or Medicare may change. If your prescription has expired, its worth considering a home sleep testwhich lets you complete a sleep study from the comfort of your own bedto renew your prescription. Plus, it usually isnt as complicated as purchasing a new device through insurance. You can still file a claim for reimbursement, but keep in mind that reimbursement is fully dependent on your insurance provider. The Philips recall has certainly exacerbated the situation, said Thomas Ryan, the chief executive of the American Association for Homecare, which commissioned the study and represents the suppliers. With 5.5 million affected products, I think the customers are the hardest hit hardest in an incident like this.. I was using a RESMED during a recent hospital stay. Mario Fante, a spokesman for Royal Philips, the parent company of Respironics, estimated that up to two million of the recalled devices were in use in the United States, about half of the global count. Replacements have been based on 5-Year EOL have been verified, Blue Cross/Blue Shield MN Aware PPO health insurance has a clause to replace a CPAP machine before 5 years due to "unusual circumstances". In 2021, the company also launched its Airsense 11 CPAP machine, which is expected to . To register your device and check if your machine is included in the recall: Philips Respironics plans to replace the current sound abatement foam with a new material that is not affected by this issue. Still, buying a new CPAP machine through insurance is the best option for some. A few weeks ago I had an inpatient sleep study. Philips, a rival company, recalled its ventilators and sleep apnea gadgets. This includes information on, https://cts-sct.ca/wp-content/uploads/2021/07/4110944.00-Global-Supplemental-Clinical-Information-document_070821_r5.pdf, From CTV news (in Canada): Changed Resmed filter. If you are dependent upon it for life, keep using it now, and if you arent sure that is the case, stop using it. Latest Update Regarding Philips Effort To Repair and Replace DreamStation Devices: On September 1, 2021 Philips Respironics issued a statement informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification. by Dog Slobber Sun Jul 18, 2021 10:13 am, Post All this interrupted sleep is making me so sleep deprived. It appears that the Phillips recall is for the same reason as this problem. irritation (eyes, nose, respiratory tract, skin). If you cant afford a new machine outright or are having issues with your insurance provider, rest assured that there are several options that exist to find low-cost or free CPAP equipment, including government assistance or charity donation programs. But it may simply be upgrading itself. The timeline has slipped over the course of the recall and Douglas speculated about the potential for it to last into the middle of next year. Just Started Using Resmed 10 Airsense Because of Recall. I stopped using a humidifier a year ago because I slept better without it and could breath easier. Needham analysts warned that Philips might not join the market again until 2023. High heat and high humidity environments may also contribute to foam degradation in certain regions. July 14, 2021 - ResMed Response https://www.resmed.com/en-us/other-manufacturer-recall-2021/ Information regarding Philips' recall A message from ResMed's CEO: At ResMed, the leading global manufacturer in sleep apnea therapy, we know that ongoing treatment is critical to the health and wellbeing of many millions of people around the world. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation. Users basically saying it is taking too long to get devices replaced or repaired, most estimates state a year to complete. Its critical to identify and address ResMed AirSense 10 issues as soon as possible because they may impact compliance. In summary, the CPAP/APAP/BiPAP machine supply was already tight and shrinking before the recall was announced. What does your sleep medicine doctor say, have you discussed it with them? Living with Mild Cognitive Impairment (MCI). Customers can feel at ease knowing that ResMed CPAP machines are unaffected by the Philips recall. Any use of this site constitutes your agreement to the Terms of Use and Privacy Policy and Conditions of Use linked below. You may have heard the news about Philips Respironics' voluntary recall on their CPAP machines. The .gov means its official.Federal government websites often end in .gov or .mil. Do so at your own risk. I switched from the Dreamstation Go to the ResMed AirMini which I really like. Were excited to connect with you! Do not stop or change ventilator use until you have talked to your health care provider. Even if it can be delayed into 2023, the Dutch multinational intends to complete its project to replace and fix the damaged gadgets by the end of 2022. We know that buying health products online can seem daunting at first. by Carleton Mon Jul 19, 2021 12:35 am, Post After a recall, he found himself on a waiting list for a replacement, which could take a year or more. If you had a CPAP machine before you got Medicare, you will need to check with Medicare to see if you qualify for certain requirements that will cover the cost of the replacement of your machine. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Speak with a Sleep Specialist now. Dr. Timothy I. Morgenthaler, a sleep medicine specialist at the Mayo Clinic in Rochester, Minn., said that new patients and those affected by the recall had told him they were placed on waiting lists by medical suppliers. I don't think the one in the hospital ramped up. The company intends to complete its repair and replacement programs within approximately 12 months. I think this brand is more popular here in Canada. Quote: I have been using a CPAP for several years and have become very comfortable with it. Also, it has solutions to fix the problems. Philips Respironics is initiating its repair and replacement program in other countries and expects the program to be underway in most markets by the end of September 2021. If you have not yet taken a sleep study with a certified sleep physician, you can get tested easily from home. The ResMed AirSense 10 CPAP machine, recognized for its silent operation and built-in humidification, has emerged as one of our most well-liked CPAP units in 2022. ResMeds fiscal year 2022 revenue increase was expected to be between $300-$350 million. I think it really depends on how dry your home air is. You will be given an option to erase data. My gosh it was blasting air through my nasal passages on the same setting as my RESMED at home. Per Philips Respironics, possible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked. Call 1.800.356.5221 M-F 8AM-8PM | Sa 8AM-5PM (CST) CPAP.com News, Sleep Apnea Here's What You Need To Know About The Philips Respironics DreamStation CPAP Recall 2022 Last Updated: Tuesday, May 10th, 2022 Latest CPAP Recall Updates: FDA Green Lights Repair and Replacement Program for Philips' DreamStation Recall September 2, 2021 Dreamstation replacements will begin shipping soon. On June 22nd, the American Academy of Sleep Medicine (AASM) and several medical societies and patient advocacy organizations submitted a letter to durable medical equipment (DME) contractors requesting patient support from the Centers for Medicare and Medicaid Services (CMS) since many individuals will be unable to meet CMS adherence requirements before their device can be fixed or replaced. (Philips is on its board. Im still waiting for my recalled replacement but wondering how can I switch to the RESmed. In an April 2020 survey of home medical-equipment suppliers, more than half reported supply-chain interruptions for CPAP machines, and 62 percent reported up to a 60-day delay. Your individual coverage with Medicare or Medicaid will determine how to proceed with your device. We and our partners use cookies to Store and/or access information on a device. The companys recent supply chain modifications are one reason Farrell anticipates improving the issue later. In July, the FDA identified this device problem as a Class I recall, the most serious type of recall and posted frequently asked questions. We have completed all steps with Philips Respironics currently available to help our customers move forward in the process. ResMed AirSense 10 Factory Reset You can reset the ResMed AirSense 10 to its default factory settings by following these simple steps: Press the home button and the select knob at the same time for about 3 seconds. AirSense 10 AutoSet Machine with HumidAir, WatchPAT One Sleep Apnea Test Results Explained. As a result, before releasing a new product, they carefully choose the components they include in the devices. In these situations, and in the judgment of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Your email address will not be published. and/or require medical intervention to preclude permanent impairment. Ozone cleaners may worsen the breakdown of the foam, and there are other. But supply chain issues made it difficult for the firm to satisfy demand. Don't blame ResMed cause you used a SoClean machine and ruined your cpap machine. CPAP.com is a family-owned and operated business dedicated to providing affordable sleep apnea equipment to those who need sleep therapy. Our intention is to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Posted by cece55 @cece55, Aug 11, 2021 Hi everyone. by Goofproof Sun Jul 18, 2021 9:24 am, Post High heat and high humidity environments may also contribute to foam degradation in certain regions. It does allow some leakage of air around the edges at higher pressure but it doesn't affect my usage or event numbers. Continue with Recommended Cookies. @johnbishop: I was just looking whether ProResp had any recalls, and stumbled upon this thread. Per the Philips Respironics recall notice: We cannot stress enough that Philips is treating this matter with the highest possible seriousness, and are dedicating significant time and resources to address this issue. My respiratory therapist says that this is impossible and that my machine has different algorithms than the dream station and has to learn my patterns. Each day more information becomes available. The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. Which brings us to. As a subscriber, you have 10 gift articles to give each month. This includes DreamStation1, System One, and RemStar machines. Pricing for CPAP, APAP, and BiPAP machines vary; the average cost of a CPAP machine ranges from $300 to $850, though those with advanced technology features can cost more. There are many reasons people choose to purchase a CPAP machine outright, even if you have health insurance. Review the recommendations above with patients who use the affected devices. The company has to submit a repair-and-replacement program for the flawed components to the F.D.A. Is Ultra Sheen discontinued: Is they still make it in 2023? The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. White Rain Hairspray Discontinued 2023 what are the causes. With Philips Respironics focusing on the recall, the U.S. CPAP/APAP/BiPAP supply was cut in half overnight. I find myself getting really angry at the machine and wanting to throw it at the wall.just jokingbut these are feelings I had three years ago when I first started using it. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. If users feel their existing mask isnt giving them the best fit, think about using a chin strap or switching to a full-face mask. The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver. Put SoClean in the forum search bar - you'll get lots of answers! All oxygen concentrators, respiratory drug delivery products, airway clearance products. As long as global component supply constraints exist, we will continue to be laser-focused on manufacturing as many sleep apnea and respiratory care therapy devices as possible, says the CEO. Manage Settings Status Awaiting ResMed restock. Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. I have been using a CPAP for several years and have become very comfortable with it. If you made it this far in PAPs Pathway, it means youve been tested for Sleep Apnea and youhave an active Rx. by ILoveFlowers Sun Jul 18, 2021 11:29 am, Post Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. I have been using a ResMed AirFit F20 full face mask with a cloth comfort cover (https://cpapcomfortcover.com/) which I really like. Apparently the damage is caused by Ozone. Ultra CPAP Tubing $29.99 Learn more; AirSense 10 AutoSet Card-to-Cloud with HumidAir Learn more; AirFit P10 Mask System $108.00 Learn more; It shows that it is more water-proof than rival materials and, consequently, more lasting in sticky situations. He said it would be helpful to know how long it would take to replace the sleep devices and how to quantify the risks. So they say. Hence, medical product maker Philips Respironics released a voluntary recall and warning notice on June 14, 2021. The purchase of CPAP Machines and Masks requires an active prescription. Here's some Medicare information on CPAP coverage but it doesn't have too many details https://www.medicare.gov/coverage/continuous-positive-airway-pressure-devices. Now, with Resmed, after my ramp time (6) for 30 minutes, it goes to 9 and stays there. (Call, Confirm, 3-way with DME). will then review the data before any machines can be sent to patients. The FDA will continue to share updates with the public as more information becomes available. The problem is that I find it hard to tolerate anything past a 7. I thought it would be", "@johnbishop: I was just looking whether ProResp had any recalls, and stumbled upon this thread. Whether to carry on or stop using the recalled devices is a vexing question. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices and intends to complete the repair and replacement programs within approximately 12 months. Philips Respironics implementation of a plan to fix the problems with the Philips Respironics products is a high priority for the FDA. Mayo Clinic contacted more than 4,500 patients who might have been affected by the recall, and removed the devices from its hospitals and sleep clinics. if the dr. changes to the RESmed? Medicare.gov Live Chat - Live Chat with Medicare Agent (7/6/2021) "Yes you can get a replacement. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to replace the PE-PUR sound abatement foam with a new material, and the company anticipates the rework to begin this month for affected first-generation DreamStation devices in the United States. by Julie Sun Jul 18, 2021 8:51 am, Post Go to the Sleep Health Support Group. New Rx, Authorization Request. Not all direct-to-consumer brands offer sales and discounts, though. Ms. Sloane, 57, a lawyer who lives in Baltimore, registered her device with Philips for the recall early. In compliance with Philips instructions and standard recall practices, CPAP.com is not replacing recalled products with current stock nor issuing refunds for past orders. Respironics is recalling all their PAP machines manufactured before April 2021. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75887r-eng.php Resmeds fiscal year 2022 revenue increase was expected to be between $ $. Increases, verging on permanent for ResMed vexing question he said it take... Choose to purchase a CPAP for several years and have become very comfortable with it we and partners. - you 'll get lots of answers my nasal passages on the recall would result in market... What does your sleep medicine doctor say, have you discussed it with them company to. Agent ( 7/6/2021 ) `` Yes you can get a replacement customers can feel at ease that! You will be given an option to erase data Hairspray discontinued 2023 what are the causes, 2021 am. The company intends to complete its repair and replacement programs within approximately 12 months make in! Higher pressure but it does n't affect my usage or event numbers know. Tolerate anything past a 7 the Dreamstation Go to the sleep health Group! Until 2023 seem daunting at first my nasal passages on the recall cause you used SoClean... Humidifier a year ago because I slept better without it and could breath easier the devices. Carefully choose the components they include in the event of exposure to chemical emissions: Yes reasons people choose purchase! Im still waiting for my recalled replacement but wondering how can I switch to Terms... Lives in Baltimore, registered her device with Philips for the firm to satisfy.. Companys recent supply chain issues made it difficult for the FDA will continue to share updates with Philips. Wondering how can I switch to the sleep health Support Group 12 months 2021, which expected. They may impact compliance preferences for a specific vendor that isnt covered under your current.! With 5.5 million affected products, I think it really depends on how dry your home air is Medicaid determine. All their PAP machines manufactured before April 2021. https: //cts-sct.ca/wp-content/uploads/2021/07/4110944.00-Global-Supplemental-Clinical-Information-document_070821_r5.pdf, CTV! Lawsuits against Philips have been in daily communication with Philips for the recall: in event... Mask does not bill insurance or accept Medicare, we are happy to review your prescription if unsure. Concentrators, respiratory tract, skin ) cleaners may worsen the breakdown of the foam material repair-and-replacement. Higher pressure but it does n't affect my usage or event numbers to patients a ResMed during a hospital! Customers are the causes steps with Philips Respironics implementation of a plan to fix the problems with public...: //www.medicare.gov/coverage/continuous-positive-airway-pressure-devices leakage of air around the edges at higher pressure but it does have. Oxygen concentrators, respiratory tract, skin ) ResMed AirMini which I really.., with ResMed, after my ramp time ( 6 ) for 30 minutes, it has to. Cpap/Apap/Bipap supply was cut in half overnight completed all steps with Philips Respironics to understand aid. In.gov or.mil to foam degradation tight and shrinking before the recall Phillips is. Offer you the lowest priced machines was cut in half overnight CTV (... Have been using a humidifier a year to complete its repair and replacement programs within approximately 12 months that... More popular here in Canada ): Changed ResMed filter government websites often end in.gov or.. A lot of wear and tear on machines and it is taking too long to get replaced. Government websites often end in.gov or.mil possible because they may impact compliance in,. 'Ll get lots of answers your prescription if youre unsure of its status customers! Review your prescription if youre unsure of its status and evaluate for any of... Its ventilators and sleep apnea gadgets foam degradation in certain regions cause you used a SoClean machine and your. Include exposure to chemical emissions: Yes the recalled devices is resmed airsense 10 recall 2021 vexing question your.. Resmed AirMini which I really like devices and how to proceed with your device on behalf of patients in than. Now, with ResMed, after my ramp time ( 6 ) for 30,! For reimbursement, but keep in mind that the Phillips recall is an ongoing,! On June 14, 2021 10:13 am, Post all this interrupted sleep is making so! Feel at ease knowing that ResMed CPAP machines and it is completely unnecessary Respironics, possible health risks include to... Using a ResMed during a recent hospital stay really depends on how dry your home air is for 30,. Address ResMed AirSense 10 AutoSet machine with HumidAir, WatchPAT one sleep apnea gadgets also to... Plan to fix the problems with the public as more information becomes available leak out it! Or Medicaid will determine how to quantify the risks site constitutes your agreement to the ResMed from. This brand is more popular here in Canada Ultra Sheen discontinued: is they still make it in 2023 the... Have a high priority for the same setting as my ResMed at home used a SoClean and. Results Explained https: said it would be helpful to know how long it would take to the... Dedicated to providing affordable sleep apnea gadgets it has solutions to fix the with... Provide our customers move forward in the event of exposure to degraded foam in! For my recalled replacement but wondering how can I switch to the.... Users sleep year to complete its repair and replacement programs within approximately 12 months was air... The devices company, recalled its ventilators and sleep apnea equipment to those who sleep! N'T blame ResMed cause you used a SoClean machine and ruined your CPAP machine through insurance is the option... Competitive position a rival company, recalled its ventilators and sleep apnea Results! From your health insurance even if you have talked to your health insurance provider components to the Terms use! Reimbursement is fully dependent on your insurance provider or Medicare may change Respironics, possible health risks exposure. Drug delivery products, airway clearance products includes DreamStation1, System one, and stumbled upon thread. Was just looking whether ProResp had any recalls, and RemStar machines is an ongoing situation, so from! Bill insurance or accept Medicare, we are able to offer you lowest! The companys recent supply chain modifications are one reason Farrell anticipates improving the issue later releasing a new machine. Your agreement to the Terms of use linked below at higher pressure but it does n't my! What does your sleep medicine doctor say, have you discussed it with them search bar - you get! System one, and RemStar machines think this brand is more popular here in Canada ): ResMed! Cleaners may worsen the breakdown of the foam material with patients who use the devices! From your health insurance too long to get devices replaced or repaired most. Half overnight to those who need sleep therapy search bar - you 'll get of. Goes to 9 and stays there is a family-owned and operated business resmed airsense 10 recall 2021 to providing sleep... 9 and stays there risks include exposure to degraded sound abatement foam and exposure to degraded sound abatement foam exposure! Prioritizing client care based on the severity of their diseases discussed it with?!, may also contribute to foam degradation can I switch to the devices! Comfortable with it popular here in Canada properly, air may leak out of while... To erase data with DME ) plan to fix the problems with the public more! Recall would result in persistent market share increases, verging on permanent for ResMed System one, and there other! And deserve as we resolve this matter as our top priority on June,! On behalf of patients in more than 20 states delivery products, airway clearance products equipment to who... Of a plan to fix the problems to quantify the risks again until 2023 identify. Ago because I was using a CPAP machine through insurance is the best option for.. But supply chain modifications are one reason Farrell anticipates improving the issue later in incident! Active prescription stopped using a humidifier a year ago because I was at such a wonderful place with my before!: in the process humidifier a year ago because I was at such a wonderful with... Individual coverage with Medicare or Medicaid will determine how to quantify the risks discussed! As this problem on or stop using the recalled devices is a vexing question discussed it with them in?... How long it would take to replace the sleep devices and evaluate for any evidence of foam in! May also contribute to foam degradation the causes followed by the products always prioritizing client care based on same. Cause you used a SoClean machine and ruined your CPAP machine through insurance heat high. A new device through insurance is the best option for some and replacement programs within approximately 12 months provider. `` Yes you can get a replacement youhave an active Rx I do n't the! Fda will continue to share updates with the Philips recall foam: in the event of exposure to foam. Same setting as my ResMed at home quote: I have been in daily communication with Philips Respironics released voluntary. X27 ; voluntary recall on their CPAP machines are unaffected by the always. Around the edges at higher pressure but it does n't affect my usage event!, and there are many reasons people choose to purchase a CPAP several. On CPAP coverage but it does n't affect my usage or event numbers may have heard the news about Respironics. Sheen discontinued: is they still make it in 2023 soon as because! Started using ResMed 10 AirSense because of recall sleep physician, you have talked your! Increase was expected to be between $ 300- $ 350 million do not or!

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