Earlier this week, the U.S. FDA revealed that the Philips’ Respironics V60 ventilator received a Class 1 recall due to an electrical circuit fault that can use the device to malfunction. Now, Philips is investigating one patient death and four reports of patient harm possibly related to the recall.
“Out of an installed base of approximately 100,000 devices globally and millions of uses, to date Philips had received four reports of patient harm and one report of patient death potentially associated with this issue. We take these events very seriously and they are still under investigation, so we cannot provide an update yet,” said a company spokesperson in an emailed statement.
An FDA spokesperson in an emailed statement said it is “working closely” with Philips Respironics to assess the company’s recall investigation and “any associated injuries” but made no mention of the report of a patient death potentially tied to the ventilator malfunction.
“We will inform the public of any significant new information resulting from our assessment,” according to the agency’s statement.
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