BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 11654288 · Received April 13, 2021

    Report

    Report Number
    1317307-2021-00002
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 12, 2021
    Manufacturer
    CARESTREAM HEALTH
    Product Code
    IZL
    UDI-DI
    60889971019394
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE AND DETERMINED THERE WAS NO DEVICE MALFUNCTION AND THE SYSTEM IS PERFORMING AS DESIGNED AND INTENDED. THE INVESTIGATION FOUND THAT THERE WERE NO DEVICE MALFUNCTIONS AND THE INCIDENT WAS CAUSED BY THE STUDENT TECH 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. PER THE SITE, THE OPERATOR HAD INFORMAL TRAINING ON THE DRX REVOLUTION SYSTEM; HOWEVER, CSH CANNOT DETERMINE THE EXTENT OR SUITABILITY OF THE TRAINING PROVIDED. IMPROPER HANDLING OF THE DRIVE HANDLE HAS BEEN ATTRIBUTED TO THE UNINTENDED REARWARD MOTION OF THE CART. USERS OF THE DRX-REVOLUTION SHOULD GRASP THE DRIVE HANDLE ONLY. WHEN GRASPING THE FREE-FLOATING HANDLE AND THE STATIONARY SIDE COVER AT THE SAME TIME, THE USER'S HANDS DO NOT MOVE WITH THE DRIVE HANDLE AS INTENDED. THEREFORE, THE FORWARD MOTION IS IMMEDIATELY FOLLOWED BY REARWARD MOTION, AS THE USERS' HANDS STAY "WITH" THE SIDE COVERS WHICH ARE MOVING FORWARD. CARESTREAM HEALTH REPRESENTATIVE 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 SITE BIOMED REPORTED THAT A STUDENT TECH WAS MANEUVERING THE DRX REVOLUTION SYSTEM BETWEEN TWO BEDS IN A PATIENT'S ROOM. THE STUDENT BEGAN TO MOVE THE SYSTEM OUT FROM BETWEEN THE TWO BEDS AND STARTED TO TURN THE UNIT TOWARDS THE ENTRANCE/EXIT DOOR TO THE ROOM WHEN THE SYSTEM MOVED BACKWARDS TOWARD HER. ACCORDING TO THE REPORT, THE DRX REVOLUTION CONTACTED THE STUDENT TECH'S GROIN AREA. THERE WAS NO DISCOLORATION OF THE AREA, BUT THE STUDENT EXPERIENCES, AND STILL EXPERIENCES PAIN WHEN SHE TOUCHES THE AREA. THE TECH NOTED A LUMP IN THE AREA; HOWEVER, THERE WERE NO BROKEN BONES OR FRACTURES. THE TECH WAS EXAMINED IN THE EMERGENCY DEPARTMENT AFTER THE INCIDENT BUT HAS NOT NEEDED FURTHER CARE SINCE THIS TIME. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552029 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH 60889971019394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other