BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR TABLE ADVANCED CONTROL "I" BASE

    MDR report key: 7247915 · Received February 7, 2018

    Report

    Report Number
    2921578-2018-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    December 6, 2017
    Report Date
    February 7, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE SERVICE CALL TO INVESTIGATE THIS EVENT IT WAS DISCOVERED THAT PREVENTIVE MAINTENANCE ON THE TABLE WAS COMPLETED BY AN UNTRAINED 3RD PARTY. EXAMINATION OF THE TABLE BY THE MIZUHO OSI SERVICE ENGINEER FOUND NO PROBLEMS WITH TABLE, NO ISSUES WITH TABLE FOOT END BRAKE, AND THE 180 DEGREE ROTATION SAFETY LOCK FUNCTIONS WERE ALL WORKING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MIZUHO OSI THAT DURING SURGERY THE TABLE TILTED UNEXPECTEDLY, PUTTING THE PATIENT AT RISK OF FALLING OFF THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92646 MODULAR TABLE ADVANCED CONTROL "I" BASE OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR