BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA

    MDR report key: 4180028 · Received October 2, 2014

    Report

    Report Number
    4180028
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS INC
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, LEFT FEMORAL LIFT FELL OFF OSI TABLE WHILE IN USE. BAR NOTED TO HAVE 4 SCREWS THAT WHERE SUPPOSE TO HOLD T EXTENSION OF LIFT TO TABLE, NONE OF WHICH WHERE STILL ATTACHED. NO OBVIOUS PT INJURY NOTED AT THIS TIME. STAFF WAS ABLE TO PUT BED BACK TOGETHER TO FINISH PROCEDURE. BED CHECKED BY BIOMED AFTER CASE COMPLETED.======================MANUFACTURER RESPONSE FOR HANA TABLE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================MANUFACTURER REPRESENTATIVE TO PROVIDE EDUCATION ON ROUTINE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614314 HANA TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED FWZ MIZUHO ORTHOPEDIC SYSTEMS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES