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.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002 importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470 contact person- (b)(4).According to onesupport case# (b)(4).The issue could be solved by shutting off the unit for five seconds and starting it again.The ssu canada technician confirmed on 2019-01-10: the error could not be reproduced.The customer is using the device without any issue.The error did not appear again at this time.Thus the failure could not 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.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.A supplemental medwatch will be submitted after new information has been received.
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