BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR TABLE ADVANCED CONTROL "I" BASE, 120V

    MDR report key: 7545025 · Received May 25, 2018

    Report

    Report Number
    2921578-2018-00019
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 14, 2018
    Report Date
    July 19, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOOT-END MOTOR WAS TESTED AND INDICATED THE FOOT-END MOTOR ASSEMBLY WAS NEAR END OF LIFE. A NEW REPLACEMENT FOOT-END MOTOR WAS INSTALLED ON THE TABLE. THERE IS NO PREVIOUS SITE SERVICE HISTORY OF ANY SERVICE ACTIVITY PROVIDED BY MIZUHO OSI FOR THIS TABLE AND S/N.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MIZUHO OSI THAT THE TABLE DROPPED/TILTED UNEXPECTEDLY. CUSTOMER STATED THAT TABLE DROPPED AND ALMOST ROLLED A PATIENT OFF TABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MIZUHO OSI THAT THE TABLE DROPPED/TILTED UNEXPECTEDLY. CUSTOMER STATED THAT TABLE DROPPED AND ALMOST ROLLED A PATIENT OFF TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386094 MODULAR TABLE ADVANCED CONTROL "I" BASE, 120V SURGICAL TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1