BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACKMASTER

    MDR report key: 16334022 · Received February 9, 2023

    Report

    Report Number
    16334022
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 12, 2023
    Manufacturer
    FULL VISION, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TREADMILL DIDN'T ADVANCE AUTOMATICALLY AFTER THE FIRST LEVEL AND HAD TO BE SWITCHED TO MANUAL MODE. DURING THE NEXT TRANSITION TO TH3 3RD LEVEL THE TREADMILL COMPLETELY STOPPED. PT WAS ABLE TO DISMOUNT SAFELY. MANUFACTURER RESPONSE FOR FULL VISION TREADMILL, PHILIPS TMX 428 220 FULL VISION TREADMILL (PER SITE REPORTER). ONGOING DIFFICULTY WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168406 TRACKMASTER TREADMILL, POWERED IOL FULL VISION, INC. TMX428 220V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown