BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

    MDR report key: 9447624 · Received December 10, 2019

    Report

    Report Number
    2126677-2019-00018
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 26, 2019
    Report Date
    February 24, 2020
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K012389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE OF THE INJURY WAS DETERMINED TO BE DUE TO A SERVICE ERROR. DURING TROUBLESHOOTING THE TABLE MOVEMENT ISSUE, THE FE PLACED HIS HAND BETWEEN THE DRIVE CHAIN AND GEAR WHILE OPERATING THE TABLE MOVEMENT FOOT PEDAL WITH THEIR OTHER HAND. THE SERVICE MANUAL REFERENCES TO PERFORM THE LOCK OUT TAG OUT PROCEDURE WHEN PERFORMING ANY SERVICING ON THE DEVICE. IN ADDITION, THERE ARE DANGER SYMBOLS LISTED WITHIN THE SERVICE MANUAL WARNING THE SERVICE REPRESENTATIVE OF A CRUSH/MECHANICAL HAZARD WHEN WORKING AROUND MOVING PARTS AND THE FE DID NOT FOLLOW THESE WARNINGS. AS A CORRECTION FOR THE ISSUE, THE FE HAS BEEN REMINDED TO FOLLOW THE WARNING TO KEEP THEIR HANDS AWAY FROM MOVING PARTS. NO FURTHER ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE HAS INITIATED A ROOT CAUSE INVESTIGATION WHICH IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A GE FIELD ENGINEER (FE) WAS PERFORMING SERVICE TROUBLESHOOTING ON A REVOLUTION XR/D FIXED RADIOGRAPHY SYSTEM INSTALLED AT (B)(6) MEDICAL CENTER IN THE USA WHERE THE CUSTOMER REPORTED THE TABLES VERTICAL TRAVEL WOULD NOT WORK. THE FE WAS WORKING ON THE TABLES DRIVE MECHANISM WHEN THE DRIVE MOTOR ENGAGED, AND THEIR RIGHT HAND WAS CAUGHT IN THE TABLES DRIVE MECHANISM. THIS RESULTED IN BLOOD VESSEL AND TENDON DAMAGE THAT REQUIRED SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242973 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM SYSTEM, X-RAY, STATIONARY KPR GE MEDICAL SYSTEMS, LLC 2213251

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention