BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOS, TABLE BASE

    MDR report key: 24110650 · Received January 19, 2026

    Report

    Report Number
    2921578-2026-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430103957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INFORMATION OBTAINED FROM THE INVESTIGATION AND DEVICE EVALUATION, MINOR ISSUES WERE FOUND PERTAINING TO CASTER LOCKING MECHANISM AND DEVICE BATTERY BUT NONE OF THESE ISSUES ARE UNDERSTOOD TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED TILT ISSUE. THERE IS A REMOTE PROBABILITY OF TILT LOCK NOT BEING APPLIED FOR A BRIEF MOMENT WHEN THE PATIENT WAS ON THE TABLE BUT THERE IS NO EVIDENCE THAT INDICATES THAT. THE ROOT CAUSE OF THIS INCIDENT IS THUS DEEMED TO BE INCONCLUSIVE.

    Description of Event or Problem · 0

    CLINICIAN REPORTS THAT THE TABLE KEPT TILTING WITH PATIENT ON THE TABLE. ERROR CODES 1048 AND 220 C REPORTED. EVALUATION REQUIRED TO DETERMINE THE ISSUE.

    Description of Event or Problem · 0

    CLINICIAN REPORTS THAT THE TABLE KEPT TILTING WITH PATIENT ON THE TABLE. ERROR CODES 1048 AND 220 C REPORTED. EVALUATION REQUIRED TO DETERMINE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136834 TRIOS, TABLE BASE OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 7803 00842430103957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown