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Device Problem
Degraded (1153)
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Patient Problems
Renal Failure (2041); Unspecified Kidney or Urinary Problem (4503)
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Event Date 10/09/2023 |
Event Type
Injury
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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 patient has alleged kidney disease/toxicity, renal failure.Medical intervention was not specified.The device has not yet been returned to the manufacturer for investigation.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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Due to the manufacturer not receiving the device information, the following are possible recall z numbers: z-1972-2021 , z-1974-2021 , z-1973-2021 h3 other text : device not returned to manufacturer.
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Search Alerts/Recalls
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