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 stomach issues and nausea that possibly may be caused by the device.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
The manufacturer was previously 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 stomach issues and nausea that possibly may be caused by the device.There was no allegation of serious or permanent harm or injury.Medical intervention was not specified.During a gfe attempt the patient declined to respond to the questions and terminated the call.The device was not returned.The manufacturer believes they will be unable to gather additional information.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.
|