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Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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At this time the manufacturer was unable to retrieve details regarding the device information.Therefore, possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : the device has not yet been 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 manufacturer received information alleging lung and heart injuries, pain and suffering.No other clinical information or medical interventions were 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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