BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3172009 · Received June 10, 2013

    Report

    Report Number
    1720753-2013-06913
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR DRIVE 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

    IT WAS REPORTED THAT THE UNIT GAVE ERROR CODE 3 AND HAD A BURNING SMELL. THIS MEANS THE ANALOG-TO-DIGITAL CHANNEL FAILED DURING SYSTEM START-UP. WHEN THIS ERROR OCCURS, THE SYSTEM WILL NOT BOOT UP. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261485 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1