[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Printable Version +- Apnea Board Forum - CPAP | Sleep Apnea (https://www.apneaboard.com/forums) +-- Forum: Public Area (https://www.apneaboard.com/forums/Forum-Public-Area) +--- Forum: Main Apnea Board Forum (https://www.apneaboard.com/forums/Forum-Main-Apnea-Board-Forum) +--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS) Pages:
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 03-22-2022 MEDTECHDIVE FDA labels Philips 2018 field correction for ventilators a Class I recall Dive Brief: The FDA has labeled a 2018 corrective action from Philips affecting certain ventilators a Class I recall after the company failed to report the action to the agency despite dozens of complaints. In 2018, Philips updated maintenance protocols for certain Trilogy ventilators, requiring the replacement at "specific intervals" of the foam used to dampen sound in the machines. A Philips spokesperson said in an emailed statement: "Based on the knowledge and insights at that time, this was not considered a correction and consequently was not reported to the FDA." According to Philips, the FDA discovered the correction during a facility inspection from August to November 2021, and the agency has now been labeled the correction a Class I recall, affecting about 230,000 units. FDA labels Philips 2018 field correction for ventilators a Class I recall | MedTech Dive RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - TimaaaaaaaahRocks - 03-22-2022 (03-22-2022, 12:30 PM)btreger Wrote: A Philips spokesperson said in an emailed statement: "Based on the knowledge and insights at that time, this was not considered a correction and consequently was not reported to the FDA." According to Philips, the FDA discovered the correction during a facility inspection from August to November 2021, and the agency has now been labeled the correction a Class I recall, affecting about 230,000 units. correction [ kuh-rek-shuhn ] noun 1. something that is substituted or proposed for what is wrong or inaccurate; emendation. 2. the act of correcting. In the FDA's facility inspection form, called a Form 483, the agency wrote that the company did not notify the agency despite having reports of foam breaking down in Trilogy and other machines as early as 2014. The field correction was initiated in response to several complaints and at least one failure from a Trilogy machine caused by foam degradation, and the foam was later found to be "mutagenic, cytotoxic, carcinogenic, and non-biocompatible. Correction? What correction? "Tis but a scratch" RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 03-22-2022 (03-22-2022, 12:52 PM)TimaaaaaaaahRocks Wrote: Correction? What correction? "Tis but a scratch" Are you referring to Monty Python or Shakespeare, or both? RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - TimaaaaaaaahRocks - 03-22-2022 (03-22-2022, 03:54 PM)btreger Wrote: Are you referring to Monty Python or Shakespeare, or both? Monty Python, Shakespeare, and Frans van Houten! Australia - Class Action - chasmm - 03-23-2022 I saw this on FB today. It's an Aussie law firm's statement on a potential class action in Australia. Take from it what you may... Quote:From Slater and Gordon (Australia) regarding the Philips class action: My recall experience and threats to charge me - Aero Man - 03-24-2022 My brand new DS1 unit was in-service for less than 1 year when the recall was announced. I registered the DS1 on 6/16/21 and today - 3/23/22 - a replacement DS1 blower unit with a User Manual and instructions, 1 extra-fine pollen filter, return label and packaging tape strip were delivered to my porch. Not included: a modem, humidifier, power supply, power cord, and tubing. The shipment was double-boxed with instructions to return the original blower. I get that these components were not affected by the recall so was not surprised that only the blower was provided. On the bottom of the refurbished unit is a prominent label: "Recertified Device". Originally, a brand new device with an expected life of 5 years was provided to me from my DME, yet this recall replacement is refurbished, not new. For the refurb, I have no idea what the remaining usable life of the motor actually is. The limited warranty for the refurbished unit is stated to be two years, so will it start whining in 2 years plus 1 day? And, with their demonstrated capability in managing this recall, who knows how long it would take Philips to provide a serviced or replacement unit under their "warranty"...weeks, months, years? One of the included docs titled "Basic Setup & Return Instructions" had the following statement "...Failure to return your original device to Philips could result in your being billed for payment of that device, as you now have two devices, but only paid for one." - yeah right. The FDA has determined that the first device manufactured by Philips was defective and unsafe to use so I possess one, not two usable devices. After receiving the refurbished blower, I was intending to return the original so another victim could get a refurbished unit, but now I have even less trust in Philips who cheapened this process further with their invoicing threat. The "fine print" on this doc advises that "...your affected device may be destroyed or refurbished" - Philip's own words in the footnotes. Sounds like "destroy the evidence" to me. I expect that a real lawyer could put a monetary figure on the extended apprehension I felt by not knowing when I was to receive a replacement unit to resume my CPAP treatment. Eventually, out of desperation and for lack of meaningful status reporting from Philips (until recently forced to do so by the FDA), I eventually purchased an out-of-pocket replacement machine so my health would not be at further risk. I suspect that the figure would be much more than the salvage cost or invoiced amount for the unreturned original machine. So that summarizes my experience with the Philips recall. -Aero Man RE: My recall experience and threats to charge me - TimaaaaaaaahRocks - 03-24-2022 (03-24-2022, 12:51 AM)Aero Man Wrote: One of the included docs titled "Basic Setup & Return Instructions" had the following statement "...Failure to return your original device to Philips could result in your being billed for payment of that device, as you now have two devices, but only paid for one." - yeah right. The FDA has determined that the first device manufactured by Philips was defective and unsafe to use so I possess one, not two usable devices. They are going to send you a bill for payment? Oh heck no, and hold on to the bill just in case there is a toilet paper shortage. I recommend you send the shipping box back with nothing but YOUR invoice for YOUR labor time reimbursement. Invoice them for the time you had to spend fixing THEIR problems. Fair is fair. Use the same hourly labor rate as CEO Frans van Houten - around $2250 an hour. You had to spend two hours of your time fixing Mr van Houten problems? They owe you $4500 plus a few grand for being a victim of breach of express warranty, fraudulent misrepresentation, fraud by omission, and unjust enrichment. If they don't pay up haul them into small claims court for failure to make you whole. RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Aero Man - 03-24-2022 Thanks. To be fair, Philip's instructions stated that they "may" bill me if I don't return the original defective unit; they didn't state outright that they would bill me (the threat). I haven't decided what to do yet as there are people like me who needed to buy an out-of-pocket replacement to restart CPAP therapy due to the uncertainty caused by Philip's lack of meaningful communication...so ultimately my therapy incurred expenses for two units. And for people after me who still need a Philips recall replacement to restart their own CPAP therapy; even if I elect to return the original defective unit to help other CPAP users, it's interesting that their explanations in the footnotes of their enclosed paperwork indicated that the returned unit would be destroyed or refurbished and that "destroyed" was sequenced ahead of "refurbished" - their words. Sounds like their lawyers missed this or they believe that their user base are actually that stupid. Sigh. - Aero Man RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Dafod - 03-24-2022 Received my replacement machine from Philips the other day - unlike Aero Man I got a slightly different mix of items: 1. DS1 blower - Manufactured 2021 Nov. (so, apparently not a reconditioned unit) with zero hours on it. 2. Power supply and cord 3. Basic (non-heated) tubing 4. Carry case w/(1 pollen filter & 1 fine filter) I also got a QR code that allowed me to print out a form for the local post office for return shipping. I was instructed that I could keep all my original stuff other than the CPAP. I then performed surgery on the new unit by removing the fan casing that included the "new and improved" foam and replaced it with the foamless casing I had been using (Amazon). I then re-inserted the hacked up original casing back in my older unit and shipped that back. I checked the new unit had the latest firmware, which it did - and now I am good. Whilst I agree with others regarding the poor customer care etc. of Philips I am not going to worry anymore. In truth, when I originall pulled apart my three cpap machines I found the problematic foam to always be in perfect condition (like new) and really little dust etc in the units which provided some relief (ignoring the gassing). I have only ever soap cleaned cpap items (daily pillow and humidifier) , and honestly have never cleaned my cpap tubing (other than air). RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Moriarty - 03-25-2022 (03-20-2022, 10:30 PM)cbeissel Wrote: In Australia Carbone Lawyers are gathering participants for a class action lawsuit. ...although Slater and Gordon have been reported as telling a prospective client that they have looked into the case and decided that, under Australian Law, the prospect of winning is not good enough for them to run the case as a Settlement Funded action. |