BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIZUHO OSI

    MDR report key: 5682770 · Received May 25, 2016

    Report

    Report Number
    5682770
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    May 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HANA TABLE WAS BEING USED FOR PROCEDURE. AFTER THE PT WAS POSITIONED ON THE TABLE BUT PRIOR TO THE START OF PROCEDURE, IT WAS NOTED THAT THE BED WAS PIVOTING ON THE "PEDESTAL STYLE" WORKINGS. THE PT WAS MOVED FROM THE HANA TABLE TO AN OLDER FRACTURE TABLE. THE CASE WAS DELAYED. REFERENCE MFR: 2921578-2014-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332635 MIZUHO OSI HANA TABLE JEA MIZUHO OSI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR