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Patient 1
AN INTELLECT VMS II WAS USED IN CONJUNCTION WITH HOT PACKS. PATIENT FELT A SUDDEN SURGE IN STRENGTH OR POWER FROM THE MACHINE-COMPLAINED OF AN INCREASE IN MUSCLE SPASM IN HIS BACK AND SOMSE CHANGE IN HIS VISUAL ACUITY. THE PADS HAD BEEN PLACED LOWER LUMBAR RWEGION. AFTER THE COMPLAINT, THE MACHINE WAS TAKEN OUT OF SERVICE. MACHINE TURNED OFF, REPORTED TO SUPERVISOR AND BIOMED NOTIFIED. BIOMED WAS NOT ABLE TO FIND THE CAUSE OF THE SURGE IN POWER. BIOMED NOTIFIED THE MANUFACTURER, WHICH RECOMMENDED THE UNIT BE SENT TO THEM FOR A COMPLETE DIAGNOSTIC TESTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-92. SERVICE PROVIDED BY: UNKNOWN. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.