BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3792291 · Received January 13, 2014

    Report

    Report Number
    9680959-2014-00064
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 13, 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

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISPLAY OF A HIGH KV ERROR MESSAGE WITHIN A PATIENT PROCEDURE THEREFORE THIS MAY HAVE RESULTED IN AN ARO. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33497 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1