BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3792259 · Received January 13, 2014

    Report

    Report Number
    1720753-2014-00391
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CINE HARD DRIVE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENTLY ON BOOT UP THE SYSTEM DISPLAYED A CINE DISK ERROR MESSAGE. THERE ARE REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33379 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1