RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11C |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Hair Loss (1877); Dizziness (2194); Unspecified Heart Problem (4454); Cough (4457)
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Event Date 03/16/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging hair loss, dizziness, cough, device has strange odor, device/power cord or supply too hot to touch, difficulty breathing/short of breath related to a bipap 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 hair loss,dizziness,cough,device has strange odor, device/power cord or supply too hot to touch,difficulty breathing/short of breath related to a bipap 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 heart race.Section g3,h2 and h6 is updated with additional information in this follow-up report.
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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 visualization of particles related to a bipap 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.
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Search Alerts/Recalls
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