BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3020899 · Received March 18, 2013

    Report

    Report Number
    1720753-2013-03887
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE BOARDS AND CONNECTORS WERE RESEATED 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 THE SYSTEM MONITOR POPPED, AND THEN SMELLED A BURNING SMELL FROM THE WORKSTATION. THE SYSTEM WENT DOWN AND HAD TO REBOOT DURING A PROCEDURE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111810 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1