Description of Event or Problem · 1
RADIATION TECHNICIAN PERFORMING THE OBLIQUE PROJECTION ON PATIENT WITH THE MAMOGRAM, WHEN THE COMPRESSION WOULD NOT RELEASE THE BREAST. THE PATIENT WAS NOT INJURED. THE MAMMOGRAM HAS BEEN TAKEN OUT OF OPERATION AND IS BEING REPLACED WITH A NEW ONE. THE OLD MACHINE HAD BEEN RETURNED TO PHILIPS, THE MANUFACTURERDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY FAILURE, NONE OR UNKNOWN, SAFETY INTERLOCK/FEATURE FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.