BEUDAMED
    FDA Adverse Event Other Summary report: N

    JST-2000 CHEST SUPPORT PLATE

    MDR report key: 633776 · Received September 1, 2005

    Report

    Report Number
    2921578-2005-00003
    Event Type
    Other
    Date Received
    September 1, 2005
    Date of Event
    July 19, 2005
    Report Date
    August 18, 2005
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    JACKSON TABLE WAS USED TO POSITION A PT IN THE PRONE POSITION. THE PT WAS LOG ROLLED FROM THE BED TO THE JACKSON TABLE. THE CHEST SUPPORT BROKE ON BOTH ENDS AND THE PT WAS WITHOUT UPPER CHEST SUPPORT FOR 10 SECONDS. THE PT WAS PLACED BACK ON THE BED, AWAKENED FROM GENERAL ANESTHESIA AND CHECKED. NO INJURY WAS NOTED AT THAT TIME. SURGERY WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JST-2000 CHEST SUPPORT PLATE PATIENT SUPPORT FWY ORTHOPEDIC SYSTEMS, INC. 5840-580 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other