BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3013160 · Received March 1, 2013

    Report

    Report Number
    1720753-2013-03238
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MACHINE IS DISPLAYING AN OVERLOAD FAULT ERROR MESSAGE. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90217 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1