BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINA HAWKEYE, GENERAL ELECTRIC MEDICAL SYSTEMS

    MDR report key: 699046 · Received April 6, 2006

    Report

    Report Number
    MW1038431
    Event Type
    Malfunction
    Date Received
    April 6, 2006
    Date of Event
    January 31, 2006
    Report Date
    April 6, 2006
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE CT PORTION OF A MYOCARDIAL PERFUSION SCAN, WITH PT LYING SUPINE WITH ARMS EXTENDED ABOVE HEAD-PATIENT REPORTED THAT HIS RIGHT ELBOW CAME INTO CONTACT BETWEEN THE DETECTOR SCREEN -GANTRY- AND THE IMAGING TABLE, AS IT ROTATED AROUND THE PT. THERE IS A PORTION OF THE DETECTOR SCREEN THAT DOES NOT HAVE PRESSURE SENSOR CAPABILITY AND IT IS THOUGHT THE PT'S ELBOW GOT CAUGHT ON THIS PORTION. THE PT ROTATED WITH THE MOVING EQUIPMENT UNTIL HIS RIGHT ARM AND SHOULDER WERE TIGHTLY PINNED BETWEEN THE IMAGING DETECTOR AND THE TABLE. STAFF WERE REQUIRED TO MANUALLY MOVE THE IMAGING TABLE-FREEING THE PT'S ARM AND SHOULDER AFTER ABOUT 5-10 MINUTES. THE PT DID NOT SUSTAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINA HAWKEYE, GENERAL ELECTRIC MEDICAL SYSTEMS GAMMA CAMERA IYX GE MEDICAL SYSTEMS INFINIA KAWKEYE *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR