RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Model Number DSX900H11C |
Device Problems
Degraded (1153); Fire (1245)
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Patient Problems
Unspecified Heart Problem (4454); Cough (4457)
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Event Date 10/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : device not returned to manufacturer.
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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 that the device/power cord or supply caught fire, device was noisy and had burning smell.Patient was alleging of heart issues and cough.There was no report of serious patient harm or injury, and no medical intervention was specified.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 that the device/power cord or supply caught fire, device was noisy and had burning smell.Patient was alleging of heart issues and cough.There was no report of serious patient harm or injury, and no medical intervention was specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In previous report box d single-use device was mentioned as yes which was incorrect and corrected to no in this report.
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Search Alerts/Recalls
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