BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1367660 · Received March 13, 2009

    Report

    Report Number
    1720753-2009-02159
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 12, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP FOUND F13 50A FUSE BLOWN IN THE BATTERY CIRCUIT. HE REPLACED THE FUSE WITH CUSTOMER STOCK, THEN TESTED THE OPERATION OF THE GENERATOR BY PERFORMING NUMEROUS FILM EXPOSURES, AND CHECKING AND ASSURING THAT THE FUSE WOULD NOT FALL AGAIN. HE CHECKED AND ASSURED THAT THE UNIT WAS OPERATING ACCORDING TO MANUFACTURER'S SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE RECEIVING BLANK FILMS AND RECEIVING ERROR CODES AFTER ATTEMPTING TO TAKE A RADIOGRAPH. REBOOTING THE UNIT DIDN'T REPAIR THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1