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Device Problem
Degraded (1153)
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Patient Problem
Anxiety (2328)
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Event Date 08/28/2023 |
Event Type
malfunction
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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 patient has alleged anxiety.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer for investigation.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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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to the manufacturer.
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Search Alerts/Recalls
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