Catalog Number 66800164R |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a npwt, a renasys go is turning on, but the screen just lights up and nothing else is visible on it.As this was noticed during inspection activities, no patient was involved.
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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.The loss of negative pressure wound therapy due to an inoperative pump 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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