BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYS

    MDR report key: 3929305 · Received June 25, 2014

    Report

    Report Number
    1317307-2014-00006
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE INCIDENT IS USER ERROR. WHILE TECH 1 WAS RETRIEVING THE PLUG END, TECH 2 TURNED THE COLUMN AND TECH 1'S FINGER WAS INJURED.

    Description of Event or Problem · 1

    TECHNOLOGIST (TECH) #1 WAS ATTEMPTING TO PICK UP THE REVOLUTION'S POWER CORD THAT FELL INTO THE COLUMN OPENING AND AT THE SAME TIME ANOTHER TECH (TECH #2) TURNED THE COLUMN. AS A RESULT, TECH #1 WAS INJURED (FRACTURED THE TIP OF A FINGER AND TORE PART OF HER FINGER NAIL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369598 DRX REVOLUTION MOBILE X-RAY SYS DRX REVOLUTION IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other