BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX MOBILE REVOLUTION SYSTEM

    MDR report key: 6575549 · Received May 18, 2017

    Report

    Report Number
    1317307-2017-00010
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 18, 2017
    Manufacturer
    CARESTREAM HEALTH INC
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INVESTIGATION, THE TECH STATED THAT HE WAS ATTEMPTING TO MOVE BETWEEN AREAS OF THE HOSPITAL AND WAS STANDING ON THE SIDE OF THE DRX REVOLUTION, HOLDING A DOOR OPEN WITH HIS LEFT HAND AND DRIVING WITH HIS RIGHT HAND. THE TECH REPORTED WHEN HE WENT TO MOVE THE CART, IT MOVED, STOPPED, AND THEN JERKED, PINCHING HIS PINKY FINGER BETWEEN THE CART AND THE DOOR, FRACTURING THE FINGER. THE INSTRUCTIONS FOR USE (IFU) STATE THAT WHILE DRIVING THE DRX REVOLUTION, THE USER SHOULD STAND BEHIND THE UNIT WITH BOTH HANDS ON THE DRIVE HANDLE. THE USER DID NOT FOLLOW THE IFU'S WHICH LEAD TO THIS INCIDENT. THE CARESTREAM HEALTH (CSH) FIELD ENGINEER (FE) EVALUATED THE SYSTEM AT THE SITE AND FOUND THAT IT WAS OPERATING AS SPECIFIED. THE FE ALSO CONFIRMED THAT THIS SYSTEM WAS UP TO DATE WITH ALL REQUIRED MODIFICATIONS. NO FOLLOW UP REPORTS WILL BE SUBMITTED AND THIS CASE IS CONSIDERED CLOSED INTERNALLY.

    Description of Event or Problem · 1

    CUSTOMER SITE REPORTED THAT WHILE DRIVING THE DRX REVOLUTION, THE USER FRACTURED A FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358406 DRX MOBILE REVOLUTION SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other