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Model Number DS960TS |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Sore Throat (2396); Respiratory Tract Infection (2420); Epistaxis (4458); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/19/2021 |
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, bipap, and mechanical ventilator devices.The manufacturer received information alleging difficult to breath while using the machine, nose bleed and nasal/throat irritation or soreness.There was no report of serious 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 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 dryness of throat and nose, difficult to breath and gasping for air while using the machine, nose bleeds and nasal / throat irritation or soreness 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 b5 has been corrected and should be reported as: the manufacturer received information alleging dryness of throat and nose, difficult to breath and gasping for air while using the machine, nose bleeds and nasal / throat irritation or soreness related to a cpap device's sound abatement foam.Section h6 health effect-clinical code corrected.Section h6 updated in this report.
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Search Alerts/Recalls
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