BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX MOBILE REVOLUTION SYSTEM

    MDR report key: 7657331 · Received July 2, 2018

    Report

    Report Number
    1317307-2018-00003
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    June 17, 2018
    Report Date
    July 27, 2018
    Manufacturer
    CARESTREAM HEALTH
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE. THE INVESTIGATION FOUND THAT THERE WAS NO DEVICE MALFUNCTION AND THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE USER ADMITTED THAT THEY DID NOT USE BOTH HANDS TO DRIVE THE DRX MOBILE REVOLUTION SYSTEM AS SPECIFIED IN THE IFU. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH.

    Description of Event or Problem · 0

    THE CUSTOMER SITE ALLEGED THAT THE RAD TECH BACKED OVER HER FOOT WHEN REVERSING THE DEVICE OUT OF AN ELEVATOR. THE TECH REQUIRED STITCHES ON HER NAIL BED AND WAS OUT OF WORK FOR ONE WEEK.

    Additional Manufacturer Narrative · 1

    CARESTREAM IS IN THE PROCESS OF INVESTIGATING THIS INCIDENT AND WILL PROVIDE AN UPDATE WHEN ADDITIONAL FACTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER SITE ALLEGED THAT THE RAD TECH BACKED OVER HER FOOT WHEN REVERSING THE DEVICE OUT OF AN ELEVATOR. THE TECH REQUIRED STITCHES ON HER NAIL BED AND WAS OUT OF WORK FOR ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496399 DRX MOBILE REVOLUTION SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other