MRXPERION MR INJECTION SYSTEM

Additional Manufacturer Narrative

THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: WHILE PERFORMING A SIGNAL TO NOISE RATIO (SNR) TEST ON THE MEDRAD® MRXPERION INJECTION SYSTEM (SERIAL NUMBER (B)(6), THE TECHNOLOGIST OBSERVED THAT THE SNR RESULT WAS LOWER THAN EXPECTED. PRIOR TO REPEATING THE TEST, THE EMPLOYEE UNPLUGGED THE ENERGIZED POWER SUPPLY FROM THE WALL OUTLET AND EXPERIENCED AN ELECTRICAL SHOCK SENSATION. IN ACCORDANCE WITH HOSPITAL PROTOCOL, THE EMPLOYEE WAS EVALUATED IN THE EMERGENCY ROOM AND WAS SUBSEQUENTLY DISCHARGED. THE SITE HAS CONFIRMED THAT THE TECHNOLOGIST HAS SINCE RETURNED TO FULL DUTY WITH NO FURTHER ISSUES REPORTED.

Additional Manufacturer Narrative

ON DECEMBER 12, 2025, BAYER SERVICE VISITED THE SITE AND PERFORMED A FUNCTIONAL CHECK OF THE MEDRAD® MRXPERION INJECTION SYSTEM (SERIAL NUMBER (B)(6)), INCLUDING AN ELECTRICAL LEAKAGE TEST. THE INJECTION SYSTEM WAS CONFIRMED TO BE FUNCTIONING TO BAYER SPECIFICATIONS. ADDITIONALLY, THE HOSPITAL ELECTRICIAN TESTED THE 110V OUTLET, AND NO ISSUES WERE REPORTED. BASED ON THE INVESTIGATION, NO DEVICE MALFUNCTION WAS IDENTIFIED. THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM IS ELECTROSTATIC DISCHARGE (ESD) THAT OCCURRED WHEN THE TECHNOLOGIST INTERACTED WITH THE GROUNDED OUTLET WHILE UNPLUGGING THE UNIT WHICH HAD NOT BEEN POWERED OFF. THE MEDRAD® MRXPERION INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: ELECTRIC SHOCK HAZARD - SERIOUS PATIENT AND/OR WORKER INJURY OR DEATH MAY RESULT. TURN OFF ANY EQUIPMENT THAT COULD GENERATE A HIGH LEVEL ELECTROSTATIC CHARGE. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: WHILE PERFORMING A SIGNAL TO NOISE RATIO (SNR) TEST ON THE MEDRAD® MRXPERION INJECTION SYSTEM (SERIAL NUMBER (B)(6)), THE TECHNOLOGIST OBSERVED THAT THE SNR RESULT WAS LOWER THAN EXPECTED. PRIOR TO REPEATING THE TEST, THE EMPLOYEE UNPLUGGED THE ENERGIZED POWER SUPPLY FROM THE WALL OUTLET WITHOUT FIRST POWERING OFF THE UNIT AND EXPERIENCED AN ELECTRICAL SHOCK SENSATION. IN ACCORDANCE WITH HOSPITAL PROTOCOL, THE EMPLOYEE WAS EVALUATED IN THE EMERGENCY ROOM AND WAS SUBSEQUENTLY DISCHARGED. THE SITE HAS CONFIRMED THAT THE TECHNOLOGIST HAS SINCE RETURNED TO FULL DUTY WITH NO FURTHER ISSUES REPORTED.