BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOS, TABLE BASE

    MDR report key: 20102414 · Received August 29, 2024

    Report

    Report Number
    2921578-2024-00017
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430103957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INFORMATION OBTAINED FROM THE INVESTIGATION, IT WAS FOUND OUT THAT THERE WAS NO REPORTED PATIENT FALL AND NO PROBLEMS WITH THE DEVICE. THE HOSPITAL PERSONNEL FAILED TO LOCK THE ROTATION LEVER WHICH THE CAUSED A SWINGING MOTION OF THE TABLE PRIOR TO TRANSFERRING THE PATIENT FROM THE HOSPITAL BED TO THE TABLE. AN EDUCATIONAL IN-SERVICE WAS CONDUCTED BY THE MANUFACTURER REGARDING THE TABLE SETUP, PATIENT TRANSFER AND PATIENT SAFETY. THE IFU/OWNER'S MANUAL OF THE TABLE WAS REVIEWED FOR INFORMATION PERTAINING TO LOCKING THE ROTATION LEVER AND FOUND TO BE SUFFICIENT. THIS INCIDENT IS THUS DEEMED AS A USE ERROR AS THERE WAS A FAILURE TO FOLLOW MANUFACTURER'S RECOMMENDED GUIDELINES AND RECOGNIZED BEST PRACTICES FOR PATIENT SAFETY.

    Description of Event or Problem · 0

    A PATIENT FELL DURING THE TRANSFER FROM THE OPERATING TABLE BACK TO THE HOSPITAL BED. THE FRAME WAS SUSPECTED TO BE UNLOCKED WHICH CAUSED THE PATIENT TO FALL AND HIT THE FLOOR.

    Description of Event or Problem · 0

    A PATIENT FELL DURING THE TRANSFER FROM THE OPERATING TABLE BACK TO THE HOSPITAL BED. THE FRAME WAS SUSPECTED TO BE UNLOCKED WHICH CAUSED THE PATIENT TO FALL AND HIT THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910977 TRIOS, TABLE BASE OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 7803 00842430103957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other