BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3101528 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05633
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "GENERATOR ERROR. CANNOT FLUORO." THIS MESSAGE APPEARS WHEN THE SYSTEM DETECTS AN ERROR IN ANY OF THE REGISTERS ASSOCIATED WITH THE HIGH VOLTAGE GENERATOR. THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THIS OCCURS. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191811 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1