BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3113063 · Received May 9, 2013

    Report

    Report Number
    1720753-2013-05885
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE BATTERY PACK, LEMO RECEPTACLE, INTERCONNECT CABLE ASSEMBLY, POWER SIGNAL INTERFACE BOARD, AND THE BATTERY CHARGER BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204963 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1