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Device Problem
Degraded (1153)
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Patient Problems
Atrial Fibrillation (1729); Dyspnea (1816); Headache (1880)
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Event Date 04/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : not returned to the manufacturer.
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Event Description
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The manufacturer received a voluntary medwatch (mw5116716) regarding 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 worsening of atrial fibrillation, breathing issues, headaches.Medical intervention was heart ablation surgery and hospitalization.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 a voluntary medwatch (mw5116716) regarding 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 worsening of atrial fibrillation, breathing issues, and headaches.Medical intervention was heart ablation surgery and hospitalization.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.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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