BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1952200 · Received January 4, 2011

    Report

    Report Number
    1720753-2011-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 4, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BOOT UP BATTERY WAS REPLACED AND THE SETTINGS WERE ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENTLY THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1