BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3772088 · Received January 2, 2014

    Report

    Report Number
    1720753-2014-00047
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE I/O (INPUT/OUTPUT) TRANSITION PCB AND CONTROLLER RIBBON CABLE WERE REPLACED. THE UNIVERSAL NODE AND GENERATOR CPU WERE ALSO REPLACED. THE FLASH MEMORY AND CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A GENERATOR ERROR. THE SYSTEM AUTOMATICALLY SHUTS DOWN WHEN THE OCCURS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1