BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA IGS 520

    MDR report key: 10625159 · Received October 5, 2020

    Report

    Report Number
    9611343-2020-00003
    Event Type
    Death
    Date Received
    October 5, 2020
    Date of Event
    September 7, 2020
    Report Date
    November 19, 2020
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K181403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT REQUIRED CPR DURING A FLUOROSCOPIC GUIDED PCI (PERCUTANEOUS CORONARY INTERVENTION) PROCEDURE AND AS SUCH, NECESSITATED THE RETRACTION OF THE TABLETOP FOR A MORE STABLE SURFACE IN ORDER TO PERFORM CPR. POST-CPR, AND IN PREPARATION TO CONTINUE THE PCI, THE STAFF REALIZED THAT THE SYSTEM WAS SHUT DOWN FOR AN UNKNOWN REASON. AFTER SEVERAL ATTEMPTS TO TROUBLESHOOT THE LOSS OF POWER, THE TEAM REBOOTED THE SYSTEM AND THE STENT WAS SUCCESSFULLY DEPLOYED. FOLLOWING THE STENT PLACEMENT, THE PATIENTS CONDITION WORSENED, AND DESPITE ADDITIONAL LIFE SAVING MEASURES, THE PATIENT EXPIRED IN THE EXAM ROOM. AFTER REVIEW OF SYSTEM LOG FILES AND AN ELECTRICAL SCHEMATIC ANALYSIS, THE INVESTIGATION CONCLUSION IS THAT AN EMERGENCY POWER OFF BUTTON (EPO) WAS ACTIVATED (PUSHED) BY SOMEONE. THERE ARE 3 EPO BUTTONS ASSOCIATED WITH THIS SYSTEM. ONE EPO BUTTON IS LOCATED ON THE POWER DISTRIBUTION BOX (PDB) WHICH IS PROVIDED BY GE. THE PDB IN THIS INSTANCE IS LOCATED IN AN UNLOCKED, EASILY ACCESSIBLE TECHNICAL ROOM / CLOSET DOWN THE HALL FROM THE EXAM ROOM AND CONTROL ROOM. THE OTHER TWO EPO BUTTONS ARE PROVIDED AND INSTALLED BY THE USER FACILITY. ONE IS LOCATED IN THE EXAM ROOM AND THE OTHER IS LOCATED IN THE CONTROL ROOM. GE EXAMINED ALL THREE EPO BUTTONS AND DETERMINED THAT THEY APPEAR TO BE FUNCTIONING PROPERLY, THEREFORE LEADING TO THE CONCLUSION THAT ONE OF THE BUTTONS WAS PUSHED, CAUSING THE SYSTEM TO LOSE POWER. THE INVESTIGATION SHOWS NO EVIDENCE WHATSOEVER OF SYSTEM MALFUNCTION AND IT WAS CONCLUDED THAT THE GE MEDICAL DEVICE DID NOT FAIL AND DID NOT CONTRIBUTE TO THAT ADVERSE EVENT AS IT OPERATED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE PATIENT INFORMATION DUE TO HIPPA REGULATION. THE ROOT CAUSE IS UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED BY GE HEALTHCARE WITH THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WITH THE ELEMENTS AVAILABLE AT THE TIME OF THIS REPORT, GE HEALTHCARE HAS BEEN MADE AWARE THAT AN EVENT OCCURRED ON (B)(6) 2020 AT (B)(6) HOSPITAL LOCATED IN (B)(6). THE DEVICE INVOLVED IS AN INNOVA IGS 520 (SN: (B)(4)). A PATIENT WAS PUT ON THE TABLE FOR A STENT PLACEMENT. THE DEVICE BOOTED CORRECTLY. CUSTOMER STARTED THE PROCEDURE SUCCESSFULLY. BEFORE STENT PLACEMENT, THE PATIENT SUFFERED A CARDIAC ARREST. MEDICAL STAFF PREPARED THE PATIENT FOR A CPR (CARDIO PULMONARY RESUSCITATION) AND DEPLOYED THE TABLE IN CPR MODE. WHEN THE PATIENT WAS STABILIZED, CUSTOMER TRIED TO CONTINUE WITH THE PROCEDURE; HOWEVER THEY NOTICED THAT THE SYSTEM WAS OFF. THEY NEEDED APPROXIMATELY 7 MINUTES TO REBOOT THE SYSTEM. THE SYSTEM REBOOTED CORRECTLY, AND THE MEDICAL TEAM WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY. FOLLOWING THIS STENT PLACEMENT, THE PATIENT'S CONDITION WORSENED. MEDICAL STAFF WAS UNABLE TO STABILIZE THE PATIENT, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091801 INNOVA IGS 520 OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death