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Model Number DSX200T11 |
Device Problem
Degraded (1153)
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Patient Problems
Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446)
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Event Date 10/12/2022 |
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 cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged heart attack.There was no medical intervention required by the patient.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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to experience a heart attack.There was no medical intervention required by the patient.The reported event of heart attack 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.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed. section b1, b2, has been changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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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 an issue related to a cpap device's sound abatement foam.The patient has alleged heart attack.There was no medical intervention required by the patient.Upon further review, it was decided that the reported heart attack is assessed as serious injury.Section b1 and b2 has been corrected to reflect serious injury, and section h1 has been corrected to reflect serious injury.Section h6 health effect - clinical code and health effect - impact code was corrected to reflect correct information in this report.
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Search Alerts/Recalls
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