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Device Problems
Degraded (1153); Chemical Problem (2893)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2023 |
Event Type
malfunction
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Event Description
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The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received allegation of exposure to dangerous toxins.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973, and z-1974.
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Search Alerts/Recalls
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