BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3823233 · Received March 20, 2014

    Report

    Report Number
    1720753-2014-02539
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BATTERY, FILAMENT DRIVE BOARD, AND THE GENERATOR DRIVE BOARD WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM HAD A PRECHARGE ERROR. THE PRECHARGE VOLTAGE ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167344 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1