Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer: (b)(4).Contact person: (b)(6).A field service technician has been sent out for investigation on 2018-10-16.Once to device was powered up, smoke was visible from the pcb x1 connector.Technician removed the pcb for inspection.The x1 connector and socket had visible heat damage around pins 8 & 9.Technician returned to customer for a second inspection on 2018-10-29 and was able to trace the fault to pin 2 & 3 of the x1 connector.Thus the failure could be confirmed.The root cause is a defective flow sensor which caused water ingress onto the device pcb.According to service order#: (b)(4), the technician replaced the device pcb and the flow sensor.Checked out flow sensor for any leaks and all ok.Tested all functions operate correctly.According to the service protocol dated on 2018-11-02, no safety or function defects were detected.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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