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Model Number DSX500T11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Respiratory Tract Infection (2420); Taste Disorder (4422); Unspecified Respiratory Problem (4464)
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Event Date 04/01/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging burnt taste in mouth,sinus issues, stuffy, difficulty breathing/short of breath related to a cpap device's sound abatement foam.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.
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Manufacturer Narrative
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The manufacturer received information alleging burnt taste in mouth,sinus issues,stuffy,difficulty breathing/short of breath related to a cpap device's sound abatement foam.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.Additional information in section b5: the patient also alleges low pressure and sinus infections.
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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 reported an allegation of an issue related to sound abatement foam and became degraded and caused the patient to have burnt taste in mouth,sinus issues,stuffy,difficulty breathing/short of breath and low pressure and sinus infections.The medical intervention that the patient received in response to the event is currently unknown.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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