BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2960815 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01301
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE POWER CONTROL BOARD. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS WOULD NOT WORK AFTER UNPLUGGING AND PLUGGING THE POWER IN. THERE IS NO REPORT INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39985 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1