BEUDAMED
    FDA Adverse Event Summary report: N

    HANA OPERATING ROOM TABLE

    MDR report key: 2431374 · Received January 3, 2012

    Report

    Report Number
    2921578-2012-00001
    Date Received
    January 3, 2012
    Date of Event
    December 16, 2011
    Report Date
    January 3, 2012
    Manufacturer
    MIZUHO, OSI.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT CABLE WAS SENT TO THE CUSTOMER TO REPAIR THE FEMUR LIFT. ADD'L INVESTIGATION IS ONGOING AND THIS RECORD WILL BE UPDATED UPON COMPLETION ((B)(4) 2011).

    Description of Event or Problem · 1

    DURING THE SETUP OF THE 6875 HANA OPERATING ROOM TABLE, IT WAS DETERMINED THAT THE 6875-600, RIGHT FEMUR LIFT WAS INOPERABLE. THE HOSPITAL DETERMINED TO CONTINUE TO USE WHEN REQUIRED BY OPERATING THE FEMUR LIFT MANUALLY. NO PT INJURY WAS CAUSED BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANA OPERATING ROOM TABLE ORTHOPEDIC OPERATING ROOM TABLE, AC JEA MIZUHO, OSI. 6875

    Patients

    Seq Age Sex Outcome Treatment
    1