BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3826554 · Received February 28, 2014

    Report

    Report Number
    9680959-2014-00294
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 28, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS DURING A PROCEDURE WITH PT INVOLVEMENT, THEREFORE THIS MALFUNCTION MAU HAVE RESULTED IN A POSSIBLE ARO. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124041 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1