BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIA HAWKEYE

    MDR report key: 4092453 · Received September 4, 2014

    Report

    Report Number
    9613299-2014-00004
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 11, 2014
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K052434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT WAS POSITIONED WITH HER ARMS PROTRUDING FROM THE SIDES OF THE TABLE, AND A CHAIR WAS PLACED WITHIN THE DETECTOR'S OPERATION AREA. AS PART OF THE AUTOMATIC UNLOAD SEQUENCE INITIATED BY THE OPERATOR, WHILE THE DETECTORS WERE ROTATING, THE PT'S HAND WAS TRAPPED BETWEEN THE SIDE OF THE DETECTOR AND THE CHAIR. AS A RESULT THE PT'S HAND WAS "SQUEEZED," AND THE PT SUFFERED OF FIVE BROKEN BONES ON HER HAND REQUIRING A CAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541637 INFINIA HAWKEYE TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R