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Device Problem
Degraded (1153)
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Patient Problems
Renal Failure (2041); Unspecified Hepatic or Biliary Problem (4493); Renal Impairment (4499)
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Event Date 09/24/2021 |
Event Type
Injury
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Event Description
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The manufacturer received a voluntary medwatch (mw5105629) in which it was alleged that altered renal function, hepatic function alteration and renal failure.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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In previous report, the manufacturer mentioned section d1 incorrectly, which has been updated in this report.Section d1 updated / corrected.
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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 previously received information alleging visualization of particles related to a cpap device's sound abatement foam.The manufacturer received a voluntary medwatch (mw5105629) in which it was alleged that altered renal function, hepatic function alteration and renal failure.The reported event was reviewd by clinical expert and asses as serious injury but not related device.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 has been updated in this report.
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Search Alerts/Recalls
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