More than two months after a recall of certain continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) and ventilator machines, consumers tell NBC 5 Responds they’re left with few good choices as they wait for the manufacturer to replace or repair devices.
Philips tells NBC 5 Responds it’s not currently able to repair or replace the estimated three-to-four million recalled devices in use worldwide. According to the company, half the recalled machines are in the United States.
“You're told to stop using this equipment that can save your life”
“In my particular case, untreated, I stop breathing 68 times an hour,” said Don Peteuil of Allen.
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Peteuil said he was using a Philips DreamStation CPAP machine to treat his sleep apnea at home until his doctor’s office forwarded him notice of the recall.
On June 14, Philips announced a recall of some Respironics machines - saying the foam used to reduce sound can break down and be swallowed or inhaled by the user. The notice also said risks of particulate exposure to other organs may include toxic and carcinogenic effects.
The recall notice instructs consumers to talk to their doctors and register their device.
Peteuil did and two months later, he’s waiting for instructions about what to do with the machine. He said his doctor’s office told him it didn’t have enough information from the company to weigh the risks of continuing to use a recalled device versus not treating his sleep apnea.
“If you believe the medical world, they tell you that you have to use it because you could die. So, I'm sitting there pondering: I could die sometime in the future from cancer if I keep using it or I could die immediately tonight if I don't use it,” said Peteuil.
“You're told to stop using this equipment that can save your life immediately with zero plan of what to do,” Peteuil added.
Attorney: recall plans weren’t sufficient
“The company is offering people to get on a list and when they have a plan, they will be notified, but that doesn’t help people who need this machine to breathe on a nightly basis,” said Dena Young – an attorney representing users of Philips machines who have filed a class-action lawsuit against the company over the recall.
The lawsuit claims Philips “knew about these very substantial and material risks long before the recall” and there wasn’t a plan to get replacement devices to consumers quickly.
“To recall a device without appropriate measures in place to help these people who rely on this machine is really negligent,” said Young.
Philips: production ramping up on repair kits, replacement machines
Philips told NBC 5 Responds it does not comment on lawsuits.
Addressing the recall, a spokesperson for Philips wrote, in part, “Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam.”
The company pointed to the number of devices in use and said it is not able to provide an “immediate solution at this time”.
Philips also said it has increased production capacity of repair kits and replacement devices to 55,000 a week – aiming to increase production to 80,000 units a week in the fourth quarter of this year.
“As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients,” wrote Philips.
Philips is asking patients to register their machines – saying registration formally begins the repair, replacement process with the company.
In July, the Food and Drug Administration classified this recall a “Class I” recall – the most serious type of recall.
The FDA said it’s monitoring the recall, including the corrective actions taken by Philips. The FDA said the company can not distribute repair kits or replacement devices until it can show the FDA the mitigation plans. Philips has to test their repair kits and the FDA said it will review the data before the company can ship the kits to consumers.
In an email to NBC 5 Responds, the FDA wrote, “The FDA considers this a high priority and has been actively working with Philips Respironics to review and assess their mitigation plan and correct the product defects as soon as possible.”
Faced with buying a new machine out-of-pocket, Peteuil, an engineer, found another solution. He said he reconfigured his late father’s CPAP machine – following instructions he found online.
“I managed to find my way around it, but not everybody has the ability to find and program their own machines,” said Peteuil.
“It’s really a sorry state of affairs when you're leaving it to the patient to find their own replacement equipment and configure it on something that is supposed to be deadly,” he added.
If you have a Philips machine, you can find a list of impacted devices here.
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