BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILEDART EVOLUTION MX8

    MDR report key: 16501806 · Received March 7, 2023

    Report

    Report Number
    MW5115505
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    January 24, 2023
    Report Date
    March 3, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE ARE 3 SHIMADZU MOBILEDART MOBILE X-RAY MACHINES THROUGHOUT OUR FACILITIES. MOBILEDART EVOLUTION, MODEL MUX-200D, PART NUMBER 50379999-11, FISHERS SERIAL (B)(4), ZIONSVILLE SERIAL (B)(4) AND CARMEL SERIAL (B)(4), ALL MANUFACTURED BETWEEN 2019 AND 2020. THE INSULATION ON THE POWER CABLE USED TO CHARGE THE BATTERIES HAS BEEN BREACHED AT FISHERS AND THE SAME CABLE ON THE OTHER TWO UNITS ARE SHOWING SIGNS OF WEAR IN THE SAME LOCATION. IT OCCURS NEAR THE SPRING-LOADED/ RATCHETING CABLE RETRACTOR WHERE THE CABLE EXITS THE MACHINE. THERE ARE TWO PIECES OF BLACK PLASTIC THAT ARE SUPPOSED TO PROTECT THE OUTER JACKET AND PREVENT WEAR BUT, WITH CONTINUED USE, THE BLACK PLASTIC HAS WORN IN TWO PLACES ON THE SAME SIDE (THE WEAR FORMS THE SHAPE OF A "3"). THE REGION BETWEEN THE TWO SEMI-CIRCULAR WEAR PLACES HAS BECOME SHARP ENOUGH TO CUT THE JACKET. THE RESULT IS THAT THE OUTER JACKET BECOMES TORN AND EXPOSES THE INSULATION OF THE THREE WIRES INSIDE. I HAVE NOT SEEN ANY COPPER YET. THIS COULD EVENTUALLY BECOME A SAFETY HAZARD FOR THE X-RAY TECHNOLOGIST. REFERENCE REPORT: MW5115506, MW5115507.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136945 MOBILEDART EVOLUTION MX8 SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION MUX-200D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown