BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIS JACKSON TABLE

    MDR report key: 1670214 · Received April 27, 2010

    Report

    Report Number
    2921578-2009-00010
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    June 25, 2009
    Report Date
    August 14, 2009
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REVIEW DETERMINED THE PUMP INSIDE THE CONTROLLER FAILED. THE PUMP IS BEING RETURNED TO ITS ORIGINAL MANUFACTURER FOR EVAL. FEEDBACK FROM THE SUPPLIER IS EXPECTED. ADDITIONAL INFO FROM THE USER FACILITY: (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, A BURNING SMELL WAS NOTICED. BIOMED WAS CALLED AND ALL REQUIREMENT WAS UNPLUGGED AND SEQUESTERED. IT WAS DETERMINED THAT THE SMELL WAS COMING FROM THE SURGICAL TABLE. THE PT WAS EXAMINED AND NO INJURY WAS NOTED. MANUFACTURER RESPONSE COMPRESSOR IN UNIT BURNED UP. ADDITIONAL INFO FROM THE USER FACILITY: MANUFACTURER RESPONSE (AS PER REPORTER) FOR SURGICAL TABLE. DEVICE STILL UNDER WARRANTY "COMPRESSOR IN THE MODULAR UNIT HAD BURNT UP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIS JACKSON TABLE OPERATING ROOM TABLE TOP JEB MIZUHO ORTHOPEDIC SYSTEMS, INC. 6977 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other