It was reported that the device malfunctioned, not doing what it was supposed to do.The physician has stated that last week his patient had a bruise from the tourniquet.Upon further questioning, the physician stated to the charge nurse that the patient had a blood clot in the leg and felt that it may have been caused by the calibration of the machine being off.
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This complaint is being reported by zimmer biomet as (b)(4).This follow-up report is being submitted to relay additional information.The a.T.S 4000 tourniquet system was manufactured on 3 june 2016 and was 7 months old at the time this complaint was generated.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.The device was noted to have not been previously repaired.No complaint history review using view could be performed since the reported event was unable to be reproduced and no other issue was found during inspection of the device.The customer returned an a.T.S 4000 tourniquet system to zimmer biomet surgical for evaluation.Inspection and repair of a.T.S.4000 tourniquet system occurred.The repair technician tested the device and found that there were no issues with the tourniquet system.The technician installed a radio frequency warning label to the device.The a.T.S.4000 tourniquet system was then verified to be functioning as intended.The device was tested and inspected per repair instructions.The root cause of the tourniquet system causing bruising and not being properly calibrated could not be specifically determined since the reported event could not be reproduced during testing and inspection.
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