The manufacturer previously reported an allegation of an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam become degraded and cause the patient's sore throat or nasal irritation.There was no report of patient any serious harm or injury.In initial and first follow up report b4 dates in both scenarios were incorrect.The correct date should have been 06/06/2022, and follow up 06/09/2022, respectively.In section b5 additional report has been added that the patient also alleged having 'particles in device and burning sensation'.In previous report, in section h6 health effect - clinical code for burning sensation and nasal irritation was not added and 2466 was incorrectly added which has been corrected / updated in this report.
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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 burning sensation in airways, particles in device, device was noisy, burning/smoke/electrical odor and nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of patient harm or injury.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
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