It was reported that the pico soft port 15 x 20cm stop working.The device stopped working during the wound treatment.This is her 3rd pico soft port 15 x 20cm used on her wound treatment.First time patient encounter this situation where the ok, leakage & low batt signal light are on at one go.Pico pump didn¿t perform suction as usual, stop its function.
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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.Suction failure resulting in the loss of negative pressure wound therapy will not directly cause or contribute to serious injury or death, even in a clinical setting as the pico dressing can revert to managing the wound as a standard multilayer dressing.No risk to patient safety is anticipated.This event is considered not reportable pursuant to 21 cfr part 803.
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