BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3093441 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05419
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP REPORTED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED. THE BOARDS AND CONNECTORS WERE RESEATED 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

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT BOOT UP. 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
    181721 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 6800

    Patients

    Seq Age Sex Outcome Treatment
    1