Maquet medical systems, usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.Reference exemption # e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person- (b)(6).The field service technician (fst) was onsite and replaced the defective printed circuit board(pcb).According to the fst the vacuum valves caused the incident.As they were damaged, water could pass the vacuum valves and arrived on the pcb.In contact with water the pcb generated sparks and fumes.As the root cause for the defective pcb is known (leaky vacuum valve), no further investigation for the pcb is necessary.The root cause for the defect of the vacuum valves is an inadequate cleaning procedure which degrades the functionality of the vacuum valve.Thus the failure could be confirmed.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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