A device was returned to a third-party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device, the third-party service center visually inspected the device and found no evidence of foam degradation.In addition, the third-party service center found corrosion in device and also corrosion of power supply connector.The device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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The manufacturer received information in relation to a dreamstation auto bipap unit.The device was returned to a third party service center.During visual inspection of the device, it was determined corrosion in the device and connector oxide contamination.Device was scrapped at customer's request.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.
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