Authorized distributor in (b)(6) reports domestic repair of device, replacing the cpu board, after having encountered unspecified failure(s).Based on the info received, the potential risk associated with the reported event is classified as serious since it might result in hypoxia.A defective cpu board could potentially lead to termination of treatment, with high priority alarms as risk mitigations, causing insufficient ventilation of the pt.Based on the info provided at this time, including unk patient outcome, the event is considered reportable per 21 cfr part 803.3.
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