The manufacturer previously received information alleging an issue related to the device's sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.In initial reports section b5 mentioned incomplete, correct b5 should be: 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 heart attack twice already from not using a device, device had a burning smell.Patient was in for surgery in october and november.Device had strange odor and particles in airway.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 health effect - clinical code has been corrected, and type of investigation, investigation findings, and investigation conclusions have been updated.Section b7, g4 has been corrected / updated in this report.
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