BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2100-IQ INTERVENTION FLUOROSCOPIC X-RAY

    MDR report key: 3692025 · Received March 13, 2014

    Report

    Report Number
    9611343-2014-00057
    Event Type
    Death
    Date Received
    March 13, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. A PHYSICIAN WAS PERFORMING AN ELECTIVE MAIN TRUNC DILATATION PROCEDURE IN WHICH THE ANGIOPLASTY HAD NOT BEGUN. THE PATIENT EXPERIENCED COMPLICATIONS AND SUFFERED A HEART ATTACK A FEW MINUTES LATER. THE X-RAY TUBE HAD FAILED A FEW SECONDS BEFORE THE PATIENT COMPLICATIONS BEGAN AND THE PHYSICIAN WAS UNABLE TO CHECK IF THE MAIN TRUNC WAS BLOCKED. THE MEDICAL STAFF PERFORMED REANIMATION ON THE PATIENT FOR MORE THAN 1.5 HOURS INCLUDING CPR, SHOCKS, VENTILATION, AND DRUG ADMINISTRATION WITHOUT SUCCESS. WHEN THE PATIENT COULD NOT BE STABILIZED, THE DOCTOR DECIDED TO TRANSFER THE PATIENT TO ANOTHER SYSTEM AN FOUND THAT THE LEFT CORONARY ARTERY WAS BLOCKED. THE PHYSICIAN UNBLOCKED THE ARTERY BUT THERE WAS NO CARDIAC ACTIVITY. THE PATIENT EXPIRED. INITIAL REPORTER EMAIL WAS NOT PROVIDED. 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 A PATIENT DIED DURING AN ELECTIVE MAIN TRUNC DILATATION PROCEDURE ON A VASCULAR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150330 INNOVA 2100-IQ INTERVENTION FLUOROSCOPIC X-RAY INTERVENTION FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death