The FDA said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination. The issue can lead to patient injury or death.
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Dutch health technology company Philips will scrap another 6,000 jobs worldwide as it tries to restore its profitability and improve the safety of its products following a recall of respiratory devices that knocked off 70% of its market value.
Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was “unlikely to result in an appreciable harm to health in patients”, provided the machines had not been treated with ozone-based cleansing products.
Philips has been recalling 5.5 million such devices since June 2021 after it became aware that a foam part can deteriorate and threaten users’ health.
Philips, which has been struggling with a major recall of ventilators, on Monday flagged further problems with some machines it has previously replaced, according to an FDA statement.
The company said it would spin off its patient monitoring and respiratory interventions businesses into a new company, as it seeks to have a more streamlined portfolio and faster revenue growth.
Dutch medical device maker Philips said on Monday it has expanded an earlier recall of some respiratory machines to a total of 1,700 devices globally due to possible contamination of a plastic component with a non-compatible material.
The agency said it received more than 48,000 reports of faulty Dutch medical equipment maker Philips’ ventilators and respiratory devices between May and July of this year.
In the months before it acknowledged its first official COVID-19 outbreak, North Korea suddenly imported millions of face masks, 1,000 ventilators, and possibly vaccines from China, trade data released by Beijing showed.
