Philips has discovered new problems with its respirators. The healthcare technology group has informed the United States FDA and regulators in other countries about this. The announcement further expands Philips’s lingering issue with sound-dampening foam coming loose in sleep apnea devices and respirators.
The case surrounding these devices has been ongoing for over a year. In some Philips devices, the insulating foam can crumble, resulting in potential health problems for users who breathe it in. Philips is in the process of replacing 5.5 million devices. Over 4 million of these have already been replaced.
The new issues concern Trilogy respirators, whose foam Philips has already replaced. The new foam could possibly loosen and block the air intake. If that happens, an alarm will sound.
According to a spokesperson for Philips, the company now has to replace approximately 170,000 Trilogy respirators. The company is just getting started with this. Only 20,000 devices have been replaced, mainly in the United States and Japan. Philips received ten reports of defective devices, according to the spokesperson. He also said that Philips had replaced no Trilogy equipment in the Netherlands.
Traces of dirt have also been found in some modified devices. Preliminary investigations indicate that these include crumbled particles of the foam. The FDA has requested additional information from Philips to better understand the cause of the new defects. The company expects to provide an update on the extent of the problems and possible actions before the end of the month.
The spokesperson could not say whether the new problems will entail additional costs for Philips. The issues with these devices already saddled the company with a cost item of hundreds of millions of euros. That is apart from legal costs for, for example, claims from angry patients.
Investors are also dissatisfied with the state of affairs. In September, the interest group for private investors Read more – NL Times