Model Number DSX500H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Taste Disorder (4422)
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Event Date 03/15/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to smelling a burning odor and a burning taste in her mouth.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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The manufacturer previously reported an allegation of an issue related to sound abatement foam.There was no report of patient harm or injury.Additional information was received an section b5 should be reported as: 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 an issue related to the device's sound abatement foam.The patient has alleged to smelling a burning odor and a burning taste in her mouth and shortness of breath.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Section h6 was updated with the appropriate health effect - clinical code as well as the type of investigation, investigation findings and investigation conclusions.
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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 to smelling a burning odor and a burning taste in her mouth and shortness of breath related to a cpap 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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.
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Search Alerts/Recalls
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