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Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Unspecified Heart Problem (4454); Dry Mouth (4485); Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/28/2023 |
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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged acute kidney failure, heart attack or heart failure, irritation, dry mouth and shortness of breath.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.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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No device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973 and z-1974.H3 other text : not returned to manufacturer.
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Search Alerts/Recalls
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