BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4353000 · Received December 18, 2014

    Report

    Report Number
    1720753-2014-09858
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    December 8, 2014
    Report Date
    December 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND T OBE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832870 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1