BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 10709498 · Received October 21, 2020

    Report

    Report Number
    1317307-2020-00005
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 20, 2020
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SITE ALLEGED THAT WHILE IN A HURRY, THE OPERATOR WAS TRYING TO HOLD A DOOR OPEN WITH ONE HAND AND DRIVE THE CART WITH THE OTHER HAND (1 HAND), ALL WHILST STANDING BESIDE THE MACHINE. AS A RESULT, THE TECH DROVE THE DRX REVOLUTION OVER HER OWN TOES (NO PATIENT INVOLVEMENT), RESULTING IN BROKEN TOES. CARESTREAM HEALTH HAS EVALUATED THE DEVICE. THE INVESTIGATION FOUND THAT THERE WERE NO DEVICE MALFUNCTIONS AND THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). PER THE IFU, THE OPERATOR MUST USE BOTH HANDS AND DRIVE BEHIND THE DRX REVOLUTION IN ORDER TO PREVENT INJURY. THE SITE BIOMED CONFIRMED THAT THE TECH DID NOT USE BOTH HANDS TO DRIVE THE REVOLUTION AS SPECIFIED IN THE IFU. CARESTREAM HEALTH REPRESENTATIVES REITERATED TO THE SITE THE IMPORTANCE OF FOLLOWING THE DRIVING INSTRUCTIONS PROVIDED WITHIN THE INSTRUCTIONS FOR USE. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER SITE ALLEGED THAT WHILE IN A HURRY, THE OPERATOR WAS TRYING TO HOLD A DOOR OPEN WITH ONE HAND AND DRIVE THE CART WITH THE OTHER HAND (1 HAND), ALL WHILST STANDING BESIDE THE MACHINE. AS A RESULT, THE TECH DROVE THE DRX REVOLUTION OVER HER TOES, RESULTING IN BROKEN TOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174075 DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. 60889978618897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other