BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2960810 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01292
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SRAM (RANDOM ACCESS MEMORY) AND THE U20 CHIP WERE REPLACED AND THE SYS SOFTWARE WAS RELOADED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A CHECKSUM ERROR MESSAGE AND WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40827 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1