BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2100-IQ

    MDR report key: 4091881 · Received August 21, 2014

    Report

    Report Number
    9611343-2014-00069
    Event Type
    Death
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 24, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. INITIAL REPORTER EMAIL WAS NOT PROVIDED. MANUFACTURING DATE IS NOT AVAILABLE AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMERGENCY ROOM PATIENT PRESENTED WITH ST SEGMENT ELEVATION INDICATING A LATERAL WALL MYOCARDIAL INFARCTION BY 12 LEAD ECG. AFTER BEING TRANSFERRED TO THE INNOVA 2100-IQ SYSTEM, THE SYSTEM FAILED TO BOOT UP. WHILE ATTEMPTING 3 UNSUCCESSFUL BOOT ATTEMPTS, THE PATIENT WENT INTO CARDIAC ARREST AND CODE PROCEDURE WAS INITIATED INCLUDING INTUBATION. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE AND FUNCTIONING SYSTEM. THE EXAM DID NOT BEGIN DUE TO THE PATIENT CONDITION AND THE PATIENT EXPIRED. THE TIME THAT ELAPSED BETWEEN SYSTEM NOT BOOTING UP AND PATIENT ARRIVAL TO ALTERNATE SYSTEM WAS APPROXIMATELY 15-20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506747 INNOVA 2100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death