BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC 9800 12

    MDR report key: 1643745 · Received March 23, 2010

    Report

    Report Number
    1720753-2010-00855
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    January 7, 2010
    Report Date
    March 22, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND THE SINGLE BOARD COMPUTER, SYSTEM INTERFACE BOARD AND GENERATOR INTERFACE BOARD NEED TO BE REPLACED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS DISPLAYING A COMMUNICATIONS ERROR AND IF THE SYSTEM IS MOVED, IT SHUTS DOWN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC 9800 12 C-ARM JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1