Information delay and lack of oversight in Phillips' CPAP Recall | Call Our Experienced Injury Lawyers
Philips has had difficulty with the ongoing recall of their CPAP and BPAP machines. It took 12 years after users first reported hearing sounds from the broken-down foam for Philips to examine the problem thoroughly. Even after the notice was issued, it only reached a few patients, and many are still waiting on their promised replacements or refunds.
Philips has had difficulty with the ongoing recall of their CPAP and BPAP machines. It took 12 years after users first reported hearing sounds from the broken-down foam for Philips to examine the problem thoroughly. Even after the notice was issued, it only reached a few patients, and many are still waiting on their promised replacements or refunds. More than a year into the recall, there have been more than 90,000 reports about problems with these devices: 260 resulted in total device failure and possible death.
The Food and Drug Administration has pulled out all the stops to force Philips to promptly contact users about the recall and replace the devices. But experts say that this response, though badly needed, underscores an unbalanced approach to medical device oversight: the FDA relies on companies like Philips to self-report any risk that may question the safety of their own devices. And when they fail, as they did with the patient pays the price.
When problems emerged, the FDA conducted inspections of Philips facilities and investigated how it responded to them. This included how it handled the foam in its ventilators and CPAP and BPAP machines-a problem that became impossible to ignore. The FDA's findings describe a company that both refused to admit a problem with its devices and failed to clearly explain its cause to consumers.
Philips has been well-aware of risks and problems with its CPAP ventilators since 2015. Customer complaints have caused Philips to take note of the degradation in foam insulation. This deterioration causes patients to breathe in potentially cancer-causing chemicals while they sleep.
The FDA found in their investigation that Philips reached out to their foam supplier in 2015 after they received customer complaints. After this, Philips found out that high temperatures and humidity could degrade the foam within a year. However, the agency did not find any evidence of Philips acting on this information.
Philips recalled 20 different models of CPAP machines, BPAP Machines, and ventilators in the company's 2020 recall. However, the whole process was a disaster. Philips couldn't contact individuals directly because it doesn't track individual device owners, instead selling most of the devices through third-party vendors. Many consumers heard about the recalled items through companies they purchased them from or because of media reports.