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Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Itching Sensation (1943); Cough (4457); Dry Mouth (4485)
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Event Date 09/09/2021 |
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 and mechanical ventilator devices.The manufacturer received information alleging itching and dryness of the throat, coughing a lot of mucus, and headaches.There was no report of serious or permanent patient harm or injury.The device was returned and the manufacturer observed the unit passed final test during device evaluation.
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Manufacturer Narrative
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Upon further review, this device was a repaired device and did not contain sound abatement foam that would be likely to cause or contribute to death or serious injury and is not in scope of (b)(4).Therefore, there is no allegation of a reportable event associated with the device at this time.
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Search Alerts/Recalls
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