BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2041476 · Received March 24, 2011

    Report

    Report Number
    1720753-2011-02748
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE POWER CORD. MANUFACTURER'S INVESTIGATION IS ONGOING FOR THE SUBTRACTION PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER CORD HAS EXPOSED WIRES, AND THE SYSTEM WILL NOT OPERATE IN SUBTRACTION MODE. NO PT OR STAFF INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1