It was reported that one renasys go is cracked and has a defective mainboard.During service and repair, the device was found to be unable to operate on ac or battery power and device cannot start up correctly and is not free from critical errors, also it does not generate alarms under expected alarm conditions.No patient involved.
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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.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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