BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2102698 · Received May 23, 2011

    Report

    Report Number
    1720753-2011-07515
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP ADJUSTED THE 5VDC VOLTAGE AT THE GENERATOR CABINET AND THE ELECTRONIC CABINET. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD LOCK UP DURING FLUOROSCOPIC X-RAY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1