BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINIA HAWKEYE 4

    MDR report key: 3202355 · Received June 13, 2013

    Report

    Report Number
    3202355
    Event Type
    Death
    Date Received
    June 13, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GENERAL ELECTRIC (GE) HEALTHCARE
    Product Code
    KPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, WHILE A (B)(6) PT WAS UNDERGOING AN INDIUM111 OCTREOSCAN (FULL BODY SCAN), THE TOP DETECTOR OF THE GA INFINIA HAWKEYE 4 SPECT/CT GAMMA CAMERA EXPERIENCED A CATASTROPHIC MECHANICAL FAILURE. PRIOR TO THE PT SCAN, THE GE INFINIA HAWKEYE 4 SPECT/CT GAMMA CAMERA PASSED A SELF TEST CHECK WITHOUT ANY PROBLEMS. THE PT WAS POSITIONED ON THE TABLE. THE SCAN STARTED. THE TABLE STARTED TO MOVE SLOWLY, AS EXPECTED, INTO THE STARTING POSITION. THE TABLE WAS SET WITH THE PT'S HEAD UNDER THE TOP DETECTOR. AS EXPECTED, THE TOP DETECTOR MOVED DOWN AND STOPPED AN INCH FROM THE PT. THE TECH STARTED THE SCAN ACQUIRING IMAGES. APPROX ONE MIN LATER, THE TOP DETECTOR FELL ON TOP OF THE PT'S HEAD AND UPPER ABDOMEN. IT THEN LOCKED INTO PLACE. THE DETECTOR WEIGHED APPROX 650 TO 800 POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269849 INFINIA HAWKEYE 4 SPECT/CT GAMMA CAMERA KPS GENERAL ELECTRIC (GE) HEALTHCARE INFINIA HAWKEYE 4

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death