It was reported that, during treatment, after a few minutes applying a renasys go to the patient, the machine blocked, leaving the screen all black.This machine had already gone to spain with the same problem reported in several times.The procedure was completed using a s+n back up device.Treatment was greater than 30mins delayed.Patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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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