BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3151357 · Received May 30, 2013

    Report

    Report Number
    9680959-2013-01043
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE CONNECTORS WERE RESEATED DURING THE SERVICE ALL. 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 THE SYSTEM TURNS OFF BY ITSELF AND TAKES A LONG TIME TO START UP AGAIN AFTERWARDS. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237630 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1