BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3792294 · Received January 10, 2014

    Report

    Report Number
    1720753-2014-00384
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    October 30, 2013
    Report Date
    January 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE AND DIRECTED THEM IN REPAIRING THE SYSTEM. THE CUSTOMER REINSTALLED THE DISPLAY BOARD FOR THE WORKSTATION. THE SYSTEM OPERATES AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A USABLE IMAGE. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20567 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1