BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LC/LPN+

    MDR report key: 349354 · Received August 23, 2001

    Report

    Report Number
    9615767-2001-00023
    Event Type
    Malfunction
    Date Received
    August 23, 2001
    Date of Event
    July 12, 2001
    Report Date
    August 22, 2001
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    IZI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN SEVERAL OCCASIONS, ON REQUEST OF C-ARM PIVOT AXIS MOTION USING THE SMART HANDLE - ENABLE AND TWIST LEFT OR RIGHT MOTION, THE PIVOT MOVED AT HIGH SPEED FOR 3 TO 15 DEGREES WITH A HUG VIBRATION AND RAPIDLY STOPPED. NO INJURY TO A PT OR OPERATOR HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38721 ADVANTX LC/LPN+ DIAGNOSTIC X-RAY IZI GE MEDICAL SYSTEMS EUROPE 2154096 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA