BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3042464 · Received April 3, 2013

    Report

    Report Number
    1720753-2013-04604
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 3, 2013
    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 REP EVALUATED THE SYSTEM AND REPLACED THE SRAM MEMORY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SRAM BATTERY WENT DEAD. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136982 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1