BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX MOBILE REVOLUTION SYSTEM

    MDR report key: 7141131 · Received December 21, 2017

    Report

    Report Number
    1317307-2017-00018
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 24, 2017
    Report Date
    January 26, 2018
    Manufacturer
    CARESTREAM HEALTH INC
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION, THE INCIDENT WAS CAUSED BY A BROKEN ELECTRICAL COMPONENT. THIS FAILURE IS DOCUMENTED IN THE DEVICE PRODUCT HAZARD RISK ANALYSIS (PHRA) AND THE RISK HAS BEEN MITIGATED TO AN ACCEPTABLE LEVEL. THE RISK MITIGATION INCLUDES THE SAFETY FEATURES OF THE DEVICE, FOR EXAMPLE, MULTIPLE EMERGENCY STOP BUTTONS AND A "DEAD-MAN" DRIVE HANDLE THAT STOPS DEVICE WHEN RELEASED. AS INDICATED IN THE COMPLAINT RECORD, THE DEVICE STOPPED WHEN THE HANDLE WAS RELEASED AND FUNCTIONED AS DESIGNED. THE DEVICE WAS REPAIRED AND RETURNED TO SERVICE. NO FURTHER ACTION IS REQUIRED BY CARESTREAM HEALTH AND THE INCIDENT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    CARESTREAM IS CURRENTLY INVESTIGATING THIS INCIDENT AND WILL SUBMIT A FOLLOW UP REPORT WHEN MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE SITE ALLEGES THAT THE CUSTOMER GRASPED THE HANDLE OF THE DRX REVOLUTION AND TRIED TO MOVE FORWARD BUT THE RIGHT WHEEL OF THE REVOLUTION MOVED BACKWARD. THIS INCIDENT OCCURRED IN THE ELEVATOR AND THE CUSTOMER WAS CAUGHT BETWEEN THE WALL AND THE REVOLUTION. THERE WAS NO INJURY ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    THE SITE ALLEGES THAT THE CUSTOMER GRASPED THE HANDLE OF THE DRX REVOLUTION AND TRIED TO MOVE FORWARD BUT THE RIGHT WHEEL OF THE REVOLUTION MOVED BACKWARD. THIS INCIDENT OCCURRED IN THE ELEVATOR AND THE CUSTOMER WAS CAUGHT BETWEEN THE WALL AND THE REVOLUTION. THERE WAS NO INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918585 DRX MOBILE REVOLUTION SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1