RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11 |
Device Problem
Degraded (1153)
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Patient Problem
Apnea (1720)
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Event Date 06/01/2021 |
Event Type
malfunction
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Event Description
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The manufacturer received a voluntary medwatch (mw5115976) in reference to the field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging no visualization of particles in the air path.The patient alleges sleep apnea has worsened.The patients said the "auto start feature doesn't seem like it's working".There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.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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H3 other text : device not returned to manufacturer.
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Manufacturer Narrative
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The manufacturer previously reported information 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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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Search Alerts/Recalls
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