BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKOTO INTRAVASCULAR IMAGING SYSTEM¿

    MDR report key: 12832643 · Received November 17, 2021

    Report

    Report Number
    3015551113-2021-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    November 11, 2021
    Report Date
    February 25, 2022
    Manufacturer
    INFRAREDX, INC.
    Product Code
    IYO
    UDI-DI
    00857595006432
    PMA / PMN Number
    K163345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE PRODUCT PROBLEM CONCLUDED THAT DUE TO THE DESIGN OF THE CART, A CASTER COMING OFF THE CONSOLE DID NOT PRESENT A RISK OF TIPPING/MECHANICAL HAZARD. MOREOVER, CASTER SCREWS ON CARTS BUILT SINCE 2020 ARE SUBJECT TO APPLICATION OF THREAD-LOCKING ADHESIVE AND A TORQUE SPECIFICATION. THE CART INVOLVED IN THIS COMPLAINT WAS BUILT IN 2016 PRIOR TO THE USE OF THREAD-LOCKING ADHESIVE AND A TORQUE SPECIFICATION. IN RESPONSE TO THIS COMPLAINT, THE TVC-MC10 FIELD SERVICE MANUAL WAS REVISED TO INCLUDE A CASTER BOLT CHECK AT PREVENTATIVE MAINTENANCE. IN ADDITION, THE DESIGN FMEA WAS UPDATED TO ADD AN ADDITIONAL ATTRIBUTE SPECIFICATION REGARDING CONSOLE CASTERS.

    Description of Event or Problem · 0

    ONE OF THE FRONT WHEEL CASTERS OF THE MC10 IMAGING SYSTEM WAS REPORTED TO HAVE ALMOST FALLEN OFF OF THE CONSOLE WHILE IT WAS BEING MOVED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731517 MAKOTO INTRAVASCULAR IMAGING SYSTEM¿ SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO INFRAREDX, INC. TVC-MC10 00857595006432

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown