BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2961609 · Received February 11, 2013

    Report

    Report Number
    1720753-2013-01633
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE GENERATOR DRIVER BOARD AND A RIBBON CABLE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED AN OVERLOAD FAULT ERROR MESSAGE. THIS ERROR MAY CAUSE THE SYSTEM TO SHUT DOWN. 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
    59619 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1