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.The device was investigated by the manufacturer emtec 2019-02-19: the error which was described by the customer could not be traced.Possible root cause: unknown.The device was also investigated by the maquet service technician on the 2019-02-28: investigation of the problem.Failure could not be reproduced - long term test.System test performed according to the service protocol.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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