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Model Number AHX500H11 |
Device Problem
Degraded (1153)
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Patient Problems
Liver Damage/Dysfunction (1954); Nausea (1970); Pelvic Inflammatory Disease (2000); Pulmonary Dysfunction (2019); Vomiting (2144); Phototoxicity (2165); Unspecified Respiratory Problem (4464)
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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 manufacturer received information alleging nose irritation, respiratory tract irritation, nausea, vomiting, inflammatory response, liver disease/toxicity, pulmonary damage.No medical intervention was specified by the patient.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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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 nose irritation, respiratory tract irritation, nausea, vomiting, inflammatory response, liver disease/toxicity, pulmonary damage.No medical intervention was specified by the patient.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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H3 other text : device not returned to manufacturer.
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Search Alerts/Recalls
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