Philips Flags Two Additional Issues With Reworked, Placed Ventilators

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  • 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.
  • Price Action: PHG shares are down 1.21% at $13.89 during the premarket session on the last check Tuesday.
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