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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Memory Loss/Impairment (1958); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/14/2021 |
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 cloudy thinking, cognitive difficulties, and some memory issues.There was no report of serious or permanent patient harm or injury.The device was returned and passed all the test during 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 res 88058.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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