BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2891454 · Received December 6, 2012

    Report

    Report Number
    1720753-2012-10191
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 6, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PREFORMED AN ONSITE INVESTIGATION. THE BATTERIES AND SRAM (RANDOM ACCESS MEMORY) WERE REPLACED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1