Catalog Number 66801281 |
Device Problems
No Audible Alarm (1019); Alarm Not Visible (1022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2021 |
Event Type
malfunction
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Event Description
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It was reported that on june 9th, during npwt using renasys touch device on a sacral wound, the dressing became loose (foam was visually able to be seen, the seal was lost) but the pump was not registering any air leak.The pump started ramping up (as it typically would when attempting to achieve a seal) but the light was still green on pump and no alarm was going off.When clinician checked the flow meter, the flow was positive, indicating that the seal was lost.After clinician fixed dressing, the pump continued to work appropriately.Pump was switched out following day to be cautious.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H10.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.Device alarms 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.If the device continues to deliver negative pressure appropriately, the lack of an alarm 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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Search Alerts/Recalls
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