BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3882933 · Received April 4, 2014

    Report

    Report Number
    9680959-2014-00465
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    November 21, 2013
    Report Date
    April 4, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MONITOR WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY THE SYSTEM WOULD NOT DISPLAY AN IMAGE ON THE MONITOR. THIS MAY CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO DISPLAY A LIVE IMAGE. 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
    205201 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1