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Model Number 999998 |
Device Problems
Degraded (1153); Unraveled Material (1664)
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Patient Problems
Headache (1880); Liver Damage/Dysfunction (1954); Nausea (1970); Vomiting (2144); Dizziness (2194); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545)
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Event Date 08/15/2023 |
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 eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness and or headache, nausea/vomiting, kidney disease /toxicity, liver disease /toxicity.Medical intervention was not specified.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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The manufacturer previously reported information 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 eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness and or headache, nausea/vomiting, kidney disease /toxicity, liver disease /toxicity.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.On the previously submitted report, uno coding wasn't selected in section h.It is corrected on this report.
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Search Alerts/Recalls
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