BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIZUHO OSI ORTHOPEDIC TABLE

    MDR report key: 2680271 · Received June 13, 2012

    Report

    Report Number
    2921578-2012-00012
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    June 2, 2012
    Report Date
    June 13, 2012
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION TO BE COMPLETED, REQUEST FOR RETURN OF TABLE TO CUSTOMER. WILL UPDATE AFTER INVESTIGATION HAS BEEN COMPLETED ((B)(4) 2012).

    Description of Event or Problem · 1

    DURING USE OF THE MIZUHO OSI ORTHOPEDIC TABLE, THE TABLE STRUCTURE FRACTURED AND THE PT SLID TO THE FLOOR. IT WAS REPORTED THAT ADD¿L HOSPITAL EQUIPMENT WAS IN PLACE AND IT SLOWED THE PT¿S DECENT TO THE FLOOR. IT WAS ALSO NOTED BY THE HOSPITAL THAT THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIZUHO OSI ORTHOPEDIC TABLE ORTHOPEDIC OPERATING ROOM TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5855

    Patients

    Seq Age Sex Outcome Treatment
    1