The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused congestive heart failure, heart attack, post traumatic stress disorder, swallowing difficulty and low oxygen.The patient did receive medical intervention and reported to have a stent placed.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
|
The manufacturer previously submitted mdr 2518422-2022-12951-1 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 impact code was corrected.
|
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 bilevel positive airway pressure (bipap) device's sound abatement foam.The patient alleged congestive heart failure, heart attack, post traumatic stress disorder, swallowing difficulty and low oxygen.The reported event of congestive heart failure, heart attack, post traumatic stress disorder, swallowing difficulty and low oxygen 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.The patient did receive medical intervention and reported to have a stent placed. 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(s) b1, b2, has 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.
|