NOTICE: Philips Discontinues Numerous Devices and Halts Dreamstation Sales in the U.S.

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FDA

Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and Loss of Therapy

This recall involves updating instructions for using BiPAP V30, BiPAP A30, and BiPAP A40 devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.  

Affected Product 

Product Names: BiPAP V30, BiPAP A30, BiPAP A40

Unique Device Identifier (UDI)/Model:
 
00606959049635/BiPAP V30 Auto
00606959039308/BiPAP A30
00606959039476/BiPAP A40

Reason for Updates to Use Instructions

Philips Respironics, Inc. is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. 

The device may:

Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with the same patient settings.
Reboot intermittently for 5-10 seconds (stopping therapy, blank screen, single audible alert), then restart with factory default settings.
Enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours, or without a preceding reboot.

These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.

There have been 952 reported injuries. There have been 65 reports of death. 

Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy | FDA

[Narcil]

well good news keep on coming for them. "our ventilators may stop working" isn't a great look...

[btreger]

Pittsburgh Post-Gazette

Inside the raging battle at Philips: Internal fights and resignations over dangerous breathing machines

Shortly after arriving as medical director at Philips Respironics four years ago, Hisham Elzayat faced an internal crisis that threatened one of the world’s largest makers of breathing machines.

The longtime heart surgeon had pored over a spate of complaints about the company's best-selling devices, filled with an industrial foam capable of breaking down into tiny particles and fumes.

The confidential documents, which the Post-Gazette has obtained, show for the first time the surgeon was among nearly a dozen Philips engineers and others who pushed the company to warn patients about the dangers of the foam before Philips removed millions of the devices from the market in a recall in June 2021 and to later stop the company from downplaying the risks.

The new records show that as far back as 2008 — far earlier than the company disclosed—the devices' foam failed safety tests. The material received the lowest possible score for cytotoxicity, the ability of a chemical to destroy cells and increase the risk of organ damage.

Inside the raging battle at Philips over dangerous breathing machines | Pittsburgh Post-Gazette

[breathingeasy]

btreger, thanks for sharing this link. Reading how Phillips leadership failed to protect its customers made me ill. Unbelievable that this company ignored internal concerns from 2008 +.

[Narcil]

btreger, thanks for sharing this link. Reading how Phillips leadership failed to protect its customers made me ill. Unbelievable that this company ignored internal concerns from 2008 +.

sadly its all too common these days, see Boeing, and until these execs go to jail nothing will change. failing to protect their customers is rewarded by weak fines and golden exit packages.

[btreger]

Pittsburgh Post-Gazette


Editorial: Two reforms that could prevent future disasters like the Philips CPAP scandal

Fast-track approval

In the case of Philips, all of their recalled devices received FDA clearance through the 510(k) “fast-track” process, which doesn’t require any clinical testing of a device before it hits the market. This process is meant to lessen the burden for devices “substantially equivalent” to an already FDA-approved device.

However, none of the public documents Philips submitted during the 510(k) processes from 2009 to 2013, when the recalled devices were being approved, disclosed the introduction of the PE-PUR foam. This should have been impossible, as the application requires detailed documentation including design drawings and schematics.

Unique Device Identifiers

Philips’ recall effort, long overdue, was also hampered by the fact the company doesn’t track its own devices or the patients who buy them. By the time the recall effort was announced in 2021, 15 million machines were affected globally, but Philips had no idea where they were. Instead, The company relied on vendors to contact patients — private contractors who are not obligated to keep long-term records or contact information for patients.

This could have easily been prevented through one mechanism: Back in 2013, the FDA implemented a system of unique device identifiers (UDIs) for medical products. These codes help identify a device by its model and production information, like the VIN on a car. In a recall, patients can easily identify their product and find vital information about its manufacturing.

Editorial: Two reforms that could prevent future disasters like the Philips CPAP scandal | Pittsburgh Post-Gazette

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MEDTECH DIVE

Philips sue's independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests

Philips claimed PSN Labs overestimated the potential threat to patients, saying it “would have pursued a different and more focused recall” if not for the results.

Philips filed a lawsuit Monday against PSN Labs, claiming the company made mistakes in its risk analysis of the soundproofing foam used in Philips’ sleep apnea devices. If it weren’t for PSN’s results, Philips said it would have taken a different approach to its massive recall of sleep and respiratory devices, according to the complaint filed in the U.S. District Court for the Western District of Pennsylvania.

Philips sues independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests | MedTech Dive

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MEDTECH DIVE

FDA cracks down on ozone cleaners for CPAP machines

The Food and Drug Administration sent warning letters to four companies for selling devices that claim to clean continuous positive airway pressure (CPAP) machines but lack agency clearance or approval.

The FDA has not authorized devices to clean or disinfect CPAP machines. 

On Aug. 7, the FDA sent warning letters to Leel Tech, Nature's Pillows and Top Dog Direct, and Adventure Innovations. It sent another letter to Shenzhen Moyeah Intelligent Life Technology a day later. 

FDA cracks down on ozone cleaners for CPAP machines | MedTech Dive

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FDA

Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation

Reason for Correction:

Philips Respironics is correcting their Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators using Software Version 1.05.10.00 (US) to resolve several previously reported and also new safety issues that may affect the device's ability to support patient breathing. The issues include:

Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation | FDA