BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3811113 · Received March 24, 2014

    Report

    Report Number
    9680959-2014-00397
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THE SERVICE REP FIX THE SYSTEM. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE FE REPORTED THE SYSTEM WAS UNABLE TO MAKE EXPOSURES ABOVE 60 KVP. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172791 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1