BEUDAMED
    FDA Adverse Event Death Summary report: N

    9900

    MDR report key: 9517284 · Received December 24, 2019

    Report

    Report Number
    1720753-2019-00001
    Event Type
    Death
    Date Received
    December 24, 2019
    Date of Event
    December 8, 2019
    Report Date
    March 20, 2020
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED EVENT IS NOW COMPLETE. PRIOR TO THE ADVERSE EVENT ON (B)(6) 2019, LOG FILE ANALYSIS AND SYSTEM CYCLING DATA INDICATE THAT THE SYSTEM DISPLAYED THE SAME OVERLOAD FAULT ERROR MESSAGE ON 25-NOV-2019, AND HAD TO BE REBOOTED MULTIPLE TIMES. FIELD SERVICE ENGINEERS (FSES) VISITED THE SITE MULTIPLE TIMES TO DIAGNOSE THE ISSUE, HOWEVER NO REPAIRS WERE MADE. AFTER THE ADVERSE EVENT, IT WAS CONCLUDED THAT THE OVERLOAD FAULT ERRORS WERE THE RESULT OF NORMAL WEAR AND TEAR ON THE X-RAY TUBE, WHICH WAS MORE THAN 7 YEARS OLD. IN RESPONSE TO THE 25-NOV-2019 COMPLAINT, THE SYSTEM WAS NOT PROPERLY EVALUATED AS DESCRIBED BY THE 9900 SERVICE MANUAL. THE PRESCRIBED TROUBLESHOOTING AND TESTING PROCESSES WERE NOT FOLLOWED, WHICH RESULTED IN THE X-RAY TUBE NOT HAVING BEEN REPLACED. THE FAILURE TO REPLACE THE X-RAY TUBE TO ADDRESS THE FIRST REPORTED OVERLOAD FAULT ERRORS RESULTED IN THE CONTINUED USE OF THE SYSTEM BY THE CUSTOMER AND THE REPEAT OF THOSE SAME ERRORS ON 08-DEC-2019.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE¿¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT REQUIRED AN EMERGENCY CORONARY PROCEDURE TO PLACE MULTIPLE CARDIAC STENTS. DURING THE PROCEDURE THE SYSTEM DISPLAYED AN ERROR MESSAGE AND LOST FUNCTIONALITY. THE FACILITY DID NOT HAVE AN AVAILABLE BACKUP UNIT. THE SURGEON CHOSE TO TERMINATE THE PROCEDURE AND TRANSPORT THE PATIENT TO ANOTHER FACILITY. THE PATIENT EXPIRED PRIOR TO BEING ABLE TO TRANSPORT THEM TO ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311847 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC 9900 ES-7277-CMH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death