Philips Flags Two Additional Issues With Reworked, Placed Ventilators

Koninklijke Philips NV PHG flagged further problems with some ventilator machines it had previously replaced.
A Philips spokesperson said only Trilogy 100/200 ventilator models were potentially affected.
The FDA said the company had notified that the new silicone sound abatement foam, installed in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam, may potentially separate from the plastic backing and could potentially block the air inlet and thus lower the inspiratory pressure.
In addition, trace amounts of particulate matter were found in the air pathways of some reworked ventilators. Preliminary results show PE-PUR and environmental debris in some samples.
Philips has replaced more than 4 million ventilators and sleep apnoea machines over the past 18 months due to worries that the foam used in the machines could become toxic.
The spokesperson said Trilogy 100/200 ventilators represent around 3% of the recall, and no sleep apnoea machines were affected.
In August, The FDA alerted that Philips recalled certain bi-level positive airway pressure machines that may contain plastic contaminated with a non-compatible material.
If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds.
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