BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIA HAWKEYE 4

    MDR report key: 3975373 · Received July 9, 2014

    Report

    Report Number
    9613299-2014-00003
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 11, 2014
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K022960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DURING A HAWKEYE SCAN, THE PATIENT, WHO SUFFERS OF DEMENTIA, HAD LIFTED UP HER ARM TO A VERTICAL POSITION, AND WHILE THE DETECTORS WERE ROTATING (AS DONE IN A HAWKEYE SCAN), ONE OF THEM PUSHED HER ARM SUCH THAT HER ARM ROTATED BY 180 DEGREES AND BECAME TRAPPED AGAINST THE TABLE. CONSEQUENTLY, THE PATIENT BROKE HER HUMERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402170 INFINIA HAWKEYE 4 TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other