Model Number DSX700S11F |
Device Problems
Degraded (1153); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.There was no report of patient harm or injury this issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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Manufacturer Narrative
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Upon further review, the device does 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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Manufacturer Narrative
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Upon further review, it has been determined that the medical device problem code of 3189 was incorrectly submitted on the previous report.
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Search Alerts/Recalls
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