The information received by the manufacturer.Has been re-evaluated for mdr reporting.And it was determined, that this case does not meet the threshold for reporting.And is a non-reportable event.When the malfunction was noticed, an alternate treatment was used.And later, a backup device was used to continue therapy.At no time, was the patient without therapy.And no serious injury was reported.If further details are provided confirming, the occurrence of a reportable event, our files will be updated accordingly.And a further report submitted outlining both the event details and our investigations performed.
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