BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA TABLE

    MDR report key: 8930794 · Received August 26, 2019

    Report

    Report Number
    MW5089289
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 21, 2019
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE MIZUHO OSI, HANA TABLE MALFUNCTIONED. THE TABLE STOPPED GOING UP OR DOWN IN HEIGHT WHEN BUTTON PRESSED ON REMOTE OR ON THE TABLE DURING THE PROCEDURE. MIZUHO OSI, HANA TABLE REP (B)(6) CONTACTED. FDA SAFETY REPORT ID# (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725729 HANA TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED FQO MIZUHO ORTHOPEDIC SYSTEMS, INC. 6875

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR