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
Cardiac Arrest (1762); Stroke/CVA (1770)
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Event Date 08/01/2022 |
Event Type
Injury
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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 bipap, and mechanical ventilator devices.The manufacturer received information alleged to had a stroke and heart attack while using this device.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 previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 an issue related to a bipap device's sound abatement foam.The patient alleged to heart problems and a stroke.There was no medical intervention required by the patient.The reported event of heart attack, stroke and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.Section(s) b1, b2 are changed related to the complaint changing from the reported adverse event to a product problem.Section h1 is changed to reflect a malfunction.
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Manufacturer Narrative
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The manufacturer previously submitted mdr 2518422-2022-72332-1 with incorrect sections b1, b2, h1, h6.Corrections to previous mdr are made in this report as follows.Section b1 was corrected to adverse event and product problem.(only product problem was checked in previous mdr).Section b2 was corrected to other serious or important medical events.(previously it was blank).Section h1 was changed from malfunction to serious injury.Section h6- health effect - impact code was updated.
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