Additional information: 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.Device alarms and/or error messages are intended to inform the user when a device is not performing as intended so that immediate action may be taken to resolve the issue and continue treatment.This event is considered not reportable pursuant to 21 cfr part 803.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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