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Model Number 1061420 |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/26/2022 |
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 bipap, and mechanical ventilator devices.The manufacturer received information alleging difficulty in breathing.There was no report of serious or permanent patient harm or injury.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 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 previously received information alleging difficulty in breathing and affecting his teeth and sight related to a bipap device's sound abatement foam.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
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Search Alerts/Recalls
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