BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESTEAM DRX-EVOLUTION

    MDR report key: 4196065 · Received October 21, 2014

    Report

    Report Number
    1317307-2014-00018
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 21, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K091889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT WAS EVALUATED BY THE FIELD ENGINEER AT THE CUSTOMER SITE. IT WAS NOTED THAT THE ISSUE OCCURRED WHEN POWERING THE EQUIPMENT DOWN RATHER THAN ON POWER-UP BASED UPON TESTING. THE ROOT CAUSE OF THE ISSUE WAS THAT THE OTC COUNTERBALANCE WAS OUT OF ADJUSTMENT. THIS ADJUSTMENT IS PART OF THE PREVENTATIVE MAINTENANCE (PM) COMPLETED ON THE EQUIPMENT EVERY 6 MONTHS. IT WAS NOTED THAT THE PM ADJUSTMENT HAD NOT BEEN COMPLETED DURING THE RECOMMENDED TIMEFRAMES. THE COUNTERBALANCE WAS ADJUSTED AND VERIFIED TO PERFORM ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE EQUIPMENT FROZE AND THE RADIOLOGY TECHNOLOGIST (RT) COULD NOT CONTINUE WITH X-RAY IMAGING. THE RT POWERED DOWN THE EQUIPMENT AND WHEN TURNING THE POWER BACK ON, THE OVERHEAD TUBE CRANE (OTC) LOWERED AND CONTACTED THE PATIENT'S ANKLE AREA. IT IS QUESTIONABLE AS TO WHETHER THIS CAUSED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669718 CARESTEAM DRX-EVOLUTION DRX-EVOLUTION KPR CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other