BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED QX/I

    MDR report key: 384376 · Received March 20, 2002

    Report

    Report Number
    2183289-2002-00003
    Event Type
    Malfunction
    Date Received
    March 20, 2002
    Date of Event
    March 4, 2002
    Report Date
    March 19, 2002
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S ELBOW PUSHED IN THE MYLAR WINDOW TO THE EXTENT THAT THE ROTATING COMPONENTS CAUGHT THE WINDOW AND CUT THE PT'S ELBOW. THE PT REQUIRED STITCHES FOR THE CUT. THE FIELD ENGINEER AND THE SITE CONFIRMED THAT THE MYLAR WINDOW WAS PROPERLY IN PLACE AND NOT DEFECTIVE. THE PT WAS FROM THE ICU AND DESCRIBED BY THE SITE AS "COMBATIVE". PT WAS RECEIVING A BODY SCAN WITH PT'S ARMS OVER THEIR HEAD USING THE PT POSITIONING STRAPS. AS THE EXAM WAS PROGRESSING THE PT BEGAN TO AGGRESSIVELY THRASH AND FORCED ELBOW INTO THE MYLAR WINDOW RESULTING IN THE INJURY. THE OPERATOR TERMINATED THE EXAM AND REMOVED THE PT FROM THE TABLE. THE MYLAR WINDOW HAS BEEN REPLACED AND THE SYSTEM IS OPERATING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED QX/I COMPUTED TOMOGRAPHY JAK GE MEDICAL SYSTEMS 2180482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other