Information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.It was determined that this event did not lead to death or serious deterioration in the state of health of a patient, user or other person.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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