BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM

    MDR report key: 13973540 · Received April 1, 2022

    Report

    Report Number
    1317307-2022-00003
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 31, 2022
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE AND DETERMINED THAT THE SYSTEM WAS OPERATIONAL AND FUNCTIONING AS DESIGNED AND INTENDED. THIS WAS A USER ERROR DUE TO NOT DOCKING THE TUBE HEAD WHILE TRANSPORTING THE DRX-REVOLUTION PLUS SYSTEM IN AN ELEVATOR WHILE IN MOTION. THIS RESULTED IN THE COLUMN TO DROPDOWN (UNDOCKED TUBE HEAD) DUE TO GRAVITY FORCE WHEN THE ELEVATOR IS MOVING DOWNWARD. THERE WAS NO PATIENT INVOLVEMENT. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE DRX-REVOLUTION PLUS SYSTEMS, IT STATES A WARNING, "RETRACT THE BOOM AND PLACE IN A DOCKED POSITION ANYTIME THE CART IS DRIVEN". THE SITE TECH (USER) WAS NOT DRIVING THE SYSTEM AS SPECIFIED IN THE IFU. IT IS UNLIKELY, IF FOLLOWING THE DRIVING RECOMMENDATIONS PROVIDED WITHIN THE IFU, THAT THIS TYPE OF INJURY WOULD OCCUR.

    Description of Event or Problem · 0

    ON 16-MAR-2022, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) HOSPITAL - (B)(6). THE SITE RADIOGRAPHER ALLEGED THAT ON (B)(6) 2022, WHILE TRANSPORTING THE DRX REVOLUTION PLUS SYSTEM THROUGH IN AN ELEVATOR, THE RADIOGRAPHER WAS HIT ON THE HEAD BY THE TUBE HEAD OF THE SYSTEM. THIS RESULTED IN A HEAD INJURY WHICH REQUIRED HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710254 DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. 60889978618897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other