BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1002757 · Received February 26, 2008

    Report

    Report Number
    1720753-2008-16395
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE BATTERY CHARGER PCB. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY, THE 9600 SYSTEM DISPLAYS CHARGER FAILED MESSAGES DURING BOOT UP. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1