It was reported that, during npwt, the renasys go was displaying an blockage/full alarm, even though the patient tried keeping the machine upright and plugged in at all times as much as possible, checking the tubing for potency/kinks, changing the dressings and changing the canister.Patient is not harmed.Further information is not available.
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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.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.Inappropriate device alarms and alarms that occur in the absence of a pump malfunction will not directly cause or contribute to serious injury or death, even in a clinical setting.Additional conditions must also exist (e.G.Surgical / treatment conditions; patient factors; the unavailability of back-up or alternate therapies for greater than 24 hours) before an injury could possibly occur, and even under those conditions, the risk of patient harm is low.This event is considered not reportable pursuant to 21 cfr part 803.
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