BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3093442 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05416
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CAMERA WAS REPLACED DURING THE SERVICE CALL. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM MONITOR SCREEN BECAME PITCH-BLACK AND WOUND NOT FLUORO, DURING A CASE. 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
    181659 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 8800

    Patients

    Seq Age Sex Outcome Treatment
    1