BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2092481 · Received May 2, 2011

    Report

    Report Number
    9680959-2011-01151
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 2, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE FOOT SWITCH WAS REPLACED THE X-RAY LAMP WAS FIXED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD TAKE X-RAYS WITHOUT THE FOOT SWITCH BEING PRESSED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1