BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOS/STS CHEST PAD SUPPORT PLATE

    MDR report key: 9728878 · Received February 19, 2020

    Report

    Report Number
    2921578-2020-00008
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 7, 2020
    Report Date
    April 9, 2020
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    UDI-DI
    00842430104343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL DISPOSED OF THE CHEST SUPPORT SECTION ASSEMBLY. HOSPITAL USED CHEST SUPPORT SECTION ASSEMBLY ON AN ALLEN SPINE FRAME, WHICH HAS NOT BEEN TESTED FOR PROPER PERFORMANCE WHEN USED AND THEREFORE ARE NOT ENDORSED FOR USE BY MIZUHO OSI. HOSPITAL DISPOSED OF THE PART.

    Description of Event or Problem · 0

    PATIENT WAS TRANSFERRED OFF OF THE TABLE AND THE STAFF NOTICED THE BROKEN PAD BASE. IT WAS FOUND THE MIZUHO OSI CHEST PAD AND SUPPORT PLATE WERE BEING USED ON AN ALLEN SPINE FRAME.

    Description of Event or Problem · 1

    PATIENT WAS TRANSFERRED OFF OF THE TABLE AND THE STAFF NOTICED THE BROKEN PAD BASE. IT WAS FOUND THE MIZUHO OSI CHEST PAD AND SUPPORT PLATE WERE BEING USED ON AN ALLEN SPINE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192546 TRIOS/STS CHEST PAD SUPPORT PLATE POSITIONER JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5840-580 00842430104343

    Patients

    Seq Age Sex Outcome Treatment
    1