SAME

Description of Event or Problem

WHILE USING 17 CM CIRCULAR COIL FOR SCANNING A LUMBAR SPINE, PATIENT COMPLAINED OF HEAT TO THE BUTTOCKS. WE IMMEDIATELY MOVED PATIENT OFF OF SURFACE COIL. SHE EXPERIENCE MINIMAL ERYTHEMIA THAT DISSIPATED BEFORE LEAVING THE DEPARTMENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUN-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.