BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESTREAM DRX-EVOLUTION

    MDR report key: 2765576 · Received September 23, 2012

    Report

    Report Number
    1317307-2012-00007
    Event Type
    Other
    Date Received
    September 23, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 21, 2012
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K091889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATED THE DEVICE AT THE CUSTOMER SITE AND FOUND THAT THE ROOT CAUSE OF THE ISSUE WAS USER RELATED. THE RADIOLOGY TECHNOLOGIST HAD PLACED PLASTIC MEDICAL TAPE TO SECURE THE DETECTOR, HOWEVER THE TAPE EXTENDED OVER THE METAL CONTACT STRIPS THAT THE X-RAY TABLE MAGNETS USED, AND ALSO ONTO THE TABLE BRAKE ITSELF. THE USE OF THIS TAPE OBSTRUCTED THE BRAKE HOLDING FORCE OF THE TABLETOP. THE SERVICE ENGINEER CLEANED THE TAPE OFF OF THE AFFECTED AREAS WHICH IMPROVED THE BRAKE FORCE, AND THE DEVICE WAS FOUND TO BE PERFORMING TO SPECIFICATIONS. THE CUSTOMER WAS INSTRUCTED NOT TO APPLY TAPE TO THE X-RAY TABLE.

    Description of Event or Problem · 1

    THE RADIOLOGY TECHNOLOGIST WAS TRANSFERRING A LARGE PT TO AN X-RAY TABLE WITH THE ASSISTANCE OF 2 OTHER TECHNOLOGISTS. THE TABLETOP MOVED LEFT TO RIGHT INTO ONE OF THE TECHNOLOGISTS POSITIONED AT EITHER END OF THE TABLE. THE TABLETOP HIT THE PERSON¿S ABDOMEN AND CAUSED BRUISING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other