BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 6015803 · Received October 10, 2016

    Report

    Report Number
    1720753-2016-02718
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 10, 2016
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE 5 VDC POWER SUPPLY CONNECTIONS WERE ADJUSTED. 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 THE SYSTEM DISPLAYED AN ERROR THAT REQUIRED A REBOOT TO REGAIN SYSTEM FUNCTIONALITY. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664824 9800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 9800 101570BI0

    Patients

    Seq Age Sex Outcome Treatment
    1