BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3151395 · Received May 30, 2013

    Report

    Report Number
    1720753-2013-06551
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. A REPAIR QUOTE WAS ISSUED TO THE CUSTOMER AND A RESPONSE IS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN OVERLOAD FAULT ERROR MESSAGE AND AN ALTERNATE SYSTEM WAS REQUIRED TO CONTINUE THE EXAM. THIS ERROR MESSAGE WILL 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
    237989 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1