BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3124049 · Received May 17, 2013

    Report

    Report Number
    1720753-2013-06180
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND ADJUSTED THE 5 VOLT POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM EXPERIENCED UNCOMMANDED GENERATOR SHUT DOWNS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218857 6800 FLOUROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1