Photo: ANP
Philips has discovered new problems with its ventilators. The healthcare technology group has notified the US FDA and regulators in other countries. This further expands Phillips’ persistent problem with sleep apnea and foam loosening in ventilators.
The case related to those devices has been ongoing for more than a year. In some Philips appliances, the insulating foam can crumble, resulting in health problems for users. Philips will replace a total of 5.5 million devices. More than 4 million of these have already been completed.
The new issues are particularly concerning the trilogy respirators, whose foam Phillips has already replaced. New foam can loosen and block air intake. If that happens, a special alarm will sound.
According to a Philips spokesperson, a total of about 170,000 related devices will need to be replaced. This company is just starting. Only 20,000 devices were completed, mainly in the US and Japan. According to the spokesperson, Philips has received ten reports of good devices. He also notes that no triage equipment has yet been replaced in the Netherlands.
Traces of dirt have also been found on some modified devices. Preliminary investigations indicate that this may include crushed particles of old foam. The FDA has requested additional information from Philips to better understand the cause of the new defects. The company expects to be able to provide an update on the severity of the issues and possible actions by the end of this month.
A spokeswoman could not say whether the new issues would result in additional costs for Philips. Problems with the devices have already cost the company hundreds of millions of euros. This is quite different for legal costs for claims from angry patients, for example.
Investors are also unhappy about the situation. A private investor interest group held Philips responsible for losses suffered by VEB shareholders in September. Damage from exchange rate losses was estimated by VEB at 16 billion euros.
Philips last month announced a 1.3 billion euro write-down on its appliances business unit. The company is seeking a settlement with the US justice system that would significantly reduce the value of its subsidiary, Respironics.
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