BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOS, TABLE BASE

    MDR report key: 11377827 · Received February 25, 2021

    Report

    Report Number
    2921578-2021-00006
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 6, 2021
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430103957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETING A PREVENTATIVE MAINTENANCE THE ONLY ISSUE FOUND WERE LOOSE BOLTS THAT MOUNT THE HEAD-END COLUMN TO THE BASE OF THE TRIOS TABLE, WHICH IS NOT RELATED TO THE TABLE TILTED ON ITS OWN. IF THE TABLE TILTED AT ALL, IT WOULD HAVE TO HAVE THE FOOT-END BRAKE PHYSICALLY RELEASE BY THE STAFF, OTHERWISE THE TABLE TILT WILL NOT OCCUR. THIS LEAD TO POTENTIAL OPERATOR ERROR, INDICATING THAT SOMEONE ON THE STAFF PHYSICAL RELEASED THE 180 DEGREE HANDLE ON THE HEAD-SECTION ASSEMBLY. WHEN YOU RELEASE THE 180 DEGREE HANDLE, BOTH AMBER LIGHTS WILL BLINK, WHICH INDICATES THAT BRAKE IS RELEASE.

    Description of Event or Problem · 0

    IT WAS REPORTED TABLETOP STARTED TILTING AT THE END OF THE PROCEDURE, LUCKILY THE NURSE CAUGHT THE PATIENT BEFORE HE/SHE FELL.

    Description of Event or Problem · 1

    IT WAS REPORTED TABLETOP STARTED TILTING AT THE END OF THE PROCEDURE, LUCKILY THE NURSE CAUGHT THE PATIENT BEFORE HE/SHE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276870 TRIOS, TABLE BASE SURGICAL OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 7803 00842430103957

    Patients

    Seq Age Sex Outcome Treatment
    1