BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX EVOLUTION SYSTEM

    MDR report key: 7062905 · Received November 28, 2017

    Report

    Report Number
    1317307-2017-00016
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 7, 2017
    Manufacturer
    CARESTREAM HEALTH INC
    Product Code
    KPR
    PMA / PMN Number
    K141837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH INVESTIGATED THE INCIDENT AND FOUND THAT THERE WAS NO MALFUNCTION. THE ROOT CAUSE WAS THAT THE USER DID NOT PROPERLY LOCK THE GRID BEFORE TURNING IT RESULTING IN IT DETACHING FROM THE DEVICE AND STRIKING THE PATIENT ON THE FOOT. THERE IS NO FURTHER ACTION REQUIRED BY CARESTREAM HEALTH.

    Description of Event or Problem · 1

    THE SITE ALLEGES THAT THE TECHNICIAN WAS USING THE WALL STAND FOR A CHEST EXAM. WHEN THE GRID WAS TURNED IT FELL OUT AND STRUCK THE PATIENT ON THE FOOT, RESULTING IN A FRACTURED BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843877 DRX EVOLUTION SYSTEM DRX EVOLUTION KPR CARESTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other