BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4921053 · Received July 15, 2015

    Report

    Report Number
    1720753-2015-02836
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 15, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE BATTERY WERE INSTALLED 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

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT BOOTING. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460645 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1