BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KODAK DIRECTIEW 7500 SYSTEM

    MDR report key: 4013950 · Received June 23, 2014

    Report

    Report Number
    1317307-2014-00008
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K051258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION TO UNDERSTAND ROOT CAUSE IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED REGARDING THE CORRECTIVE AND PREVENTIVE ACTION PLAN BASED UPON ROOT CAUSE.

    Description of Event or Problem · 1

    THE PATIENT WAS POSITIONED ON AN X-RAY TABLE TO LIE ON HER LEFT SIDE. THE RADIOLOGY TECHNOLOGIST (RT) MOVED THE X-RAY TABLETOP TO POSITION THE PATIENT FOR THE EXPOSURE. WHILE MOVING THE TABLETOP, THE TUBE AND COLLIMATOR ASSEMBLY (BETA ASSEMBLY) DISCONNECTED FROM THE OVERHEAD TUBE CRANE (OTC) TELESCOPE AND FELL ONTO A PATIENT CAUSING INJURIES THAT REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366231 KODAK DIRECTIEW 7500 SYSTEM DR 7500 KPR CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention