BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 4100

    MDR report key: 1289559 · Received January 15, 2009

    Report

    Report Number
    9611343-2009-00001
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    December 17, 2008
    Report Date
    January 15, 2009
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K023178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE, THE FACILITY HAD A BROWN OUT AND THE EQUIPMENT SHUT DOWN. THE TECHNOLOGIST REPORTEDLY REBOOTED THE SYSTEM AND SHORTLY AFTER, THE POWER STARTED TO FLICKER AGAIN. THE INNOVA'S UPS REPORTEDLY DID NOT FUNCTION DURING BOTH EVENTS. THE RADIOLOGIST ATTEMPTED TO CONTINUE WORKING WITHOUT THE ASSISTANCE OF FLUOROSCOPY. THE PATIENT REPORTEDLY HAD A STROKE AND HAS SINCE DIED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 4100 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death