BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOS ACP TABLE BASE

    MDR report key: 6745241 · Received July 26, 2017

    Report

    Report Number
    2921578-2017-00006
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    July 17, 2017
    Report Date
    September 22, 2017
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONDUCTED A PREVENTATIVE MAINTENANCE WITH NO PROBLEM FOUND, OPERATOR ERROR. ACCOUNT MANAGER PROVIDED IN-SERVICE TO RE-EDUCATED THE DOCTOR AND STAFF ON PROPER USE OF TABLE.

    Description of Event or Problem · 1

    WITH PATIENT ON THE TRIOS TABLE, THE OPERATING ROOM STAFF AND SURGEON PERFORMED 180 ROTATION. WHILE LIFTING THE ROTATION LEVER, THE SURGEON BELIEVED HE SAW THE AMBER LIGHT ON THE FOOT END FLASH BEFORE RELEASING THE HANDLE ALL THE WAY DOWN. AFTER A SUCCESSFUL ROTATION, THE STAFF WENT TO PREP FOR SURGERY AND THE SURGEON RELEASED THE ROTATION TO CHECK THE PROBLEM AGAIN. WHILE DOING SO, THE PATIENTS UPPER BODY FELL TO THE FLOOR AS THE TABLE UNLOCKED AND TILTED LATERALLY. THERE WAS A SAFETY STRAP POSITIONED NEAR THE PATIENT'S BUTTOCKS. NO INJURY HAS BEEN REPORTED.

    Description of Event or Problem · 1

    WITH PATIENT ON THE TRIOS TABLE, THE OR STAFF AND SURGEON PERFORMED 180 ROTATION. WHILE LIFTING THE ROTATION LEVER, THE SURGEON BELIEVED HE SAW THE AMBER LIGHT ON THE FOOT END FLASH BEFORE RELEASING THE HANDLE ALL THE WAY DOWN. AFTER A SUCCESSFUL ROTATION, THE STAFF WENT TO PREP FOR SURGERY AND THE SURGEON RELEASED THE ROTATION TO CHECK THE PROBLEM AGAIN. WHILE DOING SO, THE PATIENTS UPPER BODY FELL TO THE FLOOR AS THE TABLE UNLOCKED AND TILTED LATERALLY. THERE WAS A SAFETY STRAP POSITIONED NEAR THE PATIENT'S BUTTOCKS. NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524263 TRIOS ACP TABLE BASE OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 7803AP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other