BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIA II GANTRY

    MDR report key: 617874 · Received June 28, 2005

    Report

    Report Number
    9613299-2005-00002
    Event Type
    Injury
    Date Received
    June 28, 2005
    Date of Event
    June 7, 2005
    Report Date
    June 28, 2005
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    KPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S WRIST WAS BROKEN WHILE UNDER GOING A SCAN USING THE ININIA II. AS PART OF THE STATIC SCAN THE HCP REQUESTED THE PT TO PLACE THEIR OUTSTRETCHED. LEFT ARM ON A TABLE TRAY WHICH HAD BEEN POSITIONED NEXT TO GANTRY IN A POSTED, NO OBSTACLE ZONE. THE SCAN WAS UNDERTAKEN WITHOUT INCIDENT. UPON COMPLETION, THE HCP INITIATED GANTRY MOTION IN ORDER TO REMOVE THE PT. DURING ROTATIONAL MOTION, HEAD #1 COLLIDED WITH THE TRAY TABLE CAUSING THE INJURY TO THE PT'S WRIST. THE PSD STOPPED FURTHER ROTATION. THE PT WAS TREATED AT THE HOSP'S EMERGENCY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINIA II GANTRY NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS F.I. HAIFA ASM001465 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention