BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIA II 3/8 HE4 S

    MDR report key: 3184542 · Received June 19, 2013

    Report

    Report Number
    9613299-2013-00002
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 2, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K022960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    NOT APPLICABLE

    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 THE COLLIMATOR OF AN INFINIA SYSTEM FELL TO THE FLOOR DURING A COLLIMATOR EXCHANGE, HITTING AND BREAKING THE OPERATOR'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279234 INFINIA II 3/8 HE4 S SYSTEM, TOMOGRAPHY, COMPUTER EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization