The manufacturer received information regarding a dreamstation auto cpap.The device was returned to a third party service center/manufacturer 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 found evidence of foam degradation.During the evaluation, foam particles were observed inside the blower kit.In addition, cigarette smoke or insect infestation contamination was found.Corrosion was found in the power supply connector and in the device.The device was scrapped.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.
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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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