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Device Problem
Degraded (1153)
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Patient Problems
Unspecified Respiratory Problem (4464); Unspecified Hepatic or Biliary Problem (4493); Renal Impairment (4499)
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Event Date 06/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : device not returned to manufacturer.
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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 liver damage and other pulmonary damage/inflammatory response. no medical intervention was specified by the patient. the device has not yet been returned to the manufacturer for evaluation. at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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Manufacturer Narrative
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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 liver damage and other pulmonary damage/inflammatory response. no medical intervention was specified by the patient. box h: patient outcome code grid has been updated: renal impairment was entered in error.Unspecified hepatic or biliary problem has now been added per patient allegation.The device has not yet been returned to the manufacturer for evaluation. at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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Search Alerts/Recalls
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