BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3093415 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05388
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    January 16, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THIS WAS A CASE OF OPERATOR ERROR. THE SYSTEM WAS OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SYS WAS BEING LOWERED BY THE USER, A C-ARM CABLE WAS ALSO LOWERED IN A WAY IN WHICH IT CAME IN CONTACT WITH THE FOOT PEDAL, ACCIDENTALLY PRESSING THE FOOT PEDAL AND EMITTING UNINTENDED X-RAY. THERE WERE UNSHIELDED PERSONS IN THE VICINITY WHEN THE UNINTENDED EXPOSURE WAS RELEASED. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181698 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1