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 at the third-party service center, the device was visually inspected and visible foam particles were observed.Additionally, corrosion was found on the connector and contamination from dust/dirt was found.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 cpap unit.The device was returned to a third party service center.During visual inspection of the device, it was determined the power connector of the unit was corroded.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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