PHILLIPS DEAGAST U/M

Description of Event or Problem

WHILE DOING MAMMOGRAM ON PT THE SPOT COMPRESSION DEVICE WAS STUCK ON PT WHILE IN FULL COMPRESSION. RPTR TRIED TO UNLOCK COMPRESSION DEVICE AND WAS SUCCESSFUL AFTER ABOUT 30 SECS. THE PT SAID, "THAT HURT". DEVICE 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-MAY-94. SERVICE PROVIDED BY: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.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 USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.