BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINIA HAWKEYE 4

    MDR report key: 3167152 · Received June 11, 2013

    Report

    Report Number
    9613299-2013-00001
    Event Type
    Death
    Date Received
    June 11, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K022960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), THE DAY OF THE EVENT, A GE REPRESENTATIVE WAS ALLOWED INTO THE ROOM IN WHICH THE DEVICE IS INSTALLED. THE GE REPRESENTATIVE WAS ALLOWED TO BE IN THE ROOM FOR ABOUT 15-20 MINUTES ONLY TO TAKE PHOTOS. SINCE (B)(6) EVENT, REQUESTS TO ACCESS THE EQUIPMENT FOR INVESTIGATIONAL PURPOSES HAVE BEEN DENIED BY THE DEPARTMENT OF VETERANS AFFAIRS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED DUE TO INJURIES SUSTAINED WHILE BEING SCANNED ON AN (B)(4) 4 NUCLEAR MEDICINE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263985 INFINIA HAWKEYE 4 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death