BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3792285 · Received January 13, 2014

    Report

    Report Number
    9680959-2014-00069
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 26, 2013
    Report Date
    January 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE IPC 1000 BOARD 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 FE REPORTED INTERMITTENTLY THE SYSTEM FAILED TO BOOT UP. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34228 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1