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Device Problem
Degraded (1153)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/17/2021 |
Event Type
malfunction
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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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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 alleges unspecified health problems they already have are worsening.They need a replacement device soon.There is no allegation of serious or permanent harm or injury.Medical intervention was not reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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