BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2100-IQ

    MDR report key: 4975843 · Received August 4, 2015

    Report

    Report Number
    9611343-2015-00008
    Event Type
    Death
    Date Received
    August 4, 2015
    Date of Event
    June 27, 2015
    Report Date
    July 6, 2015
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K092004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL INDICATED THAT ON (B)(6) 2015, AN EMERGENCY PATIENT (MYOCARDIAL INFARCTION) WAS BROUGHT TO THE (B)(6) HOSPITAL AFTER A FULL DAY OF UNEVENTFUL DEVICE USE. THE PATIENT WAS PREPARED FOR INTERVENTION AND BROUGHT TO THE EXAM ROOM. MEANWHILE, THE SYSTEM SHUT DOWN BY ITSELF AND THE STAFF DID NOT ATTEMPT TO RESTART THE SYSTEM. INSTEAD THE PATIENT WAS IMMEDIATELY TAKEN TO ANOTHER HOSPITAL, (B)(6) HOSPITAL, WHERE AN INTERVENTION WAS COMPLETED SUCCESSFULLY DESPITE THE UNANTICIPATED EXTENDED DELAY IN TREATMENT. SOME PERIOD AFTER THE COMPLETED INTERVENTION, THE PATIENT WAS BEING TRANSFERRED BACK TO (B)(6) HOSPITAL AT WHICH TIME THEY EXPIRED. THE GE HEALTHCARE MEDICAL DIRECTOR CONFIRMED THAT BECAUSE THE ISSUE EXTENDED THE DELAY POSSIBLY AFFECTING THE PROGNOSIS, THE DEVICE FAILURE MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE ULTIMATE OUTCOME. IT HAS BEEN DETERMINED DURING TROUBLESHOOTING THAT THIS ISSUE WAS DUE TO AN INTERMITTENT FAILURE OF THE R5 RELAY WITHIN CE POWER DISTRIBUTION BOX (PDB) OF THE VASCULAR SYSTEM WHICH CAUSED THE INTERMITTENT SYSTEM SHUT DOWN. THIS RELAY IS USED TO CONTROL VOLTAGE AND PHASE OF THE FACILITY POWER SUPPLY. AUTOPSY DID NOT REVEAL ANY SPECIFIC MALFUNCTION OF THE R5 RELAY. NO PATTERN HAS BEEN IDENTIFIED WITH R5 RELAY.THE SITE HAS BEEN CORRECTED ON JULY 23, 2015 BY REPLACING THE R5 RELAY. AFTER REPLACEMENT OF THE COMPONENT, THE CE PDB AND SYSTEM WERE UP AND RUNNING. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO COUNTY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S.; THEREFORE, INITIAL REPORTER INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMERGENCY CASE ARRIVED AT THE HOSPITAL WITH A MYOCARDIAL INFARCTION. THE PATIENT WAS PREPARED FOR INTERVENTION AND BROUGHT TO THE EXAM ROOM BUT THE SYSTEM SHUT DOWN BY ITSELF. THE USER DID NOT TRY TO REBOOT THE SYSTEM AND IMMEDIATELY DECIDED TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL. THE PATIENT DIED DURING TRANSFER TO THE OTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511576 INNOVA 2100-IQ ANGIOGRAPHIC X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death