BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAR III

    MDR report key: 52230 · Received November 22, 1996

    Report

    Report Number
    52230
    Event Type
    Injury
    Date Received
    November 22, 1996
    Date of Event
    November 9, 1996
    Report Date
    November 14, 1996
    Manufacturer
    BEAR MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXPIRED TIDAL VOLUME WAS NOT REGISTERING APPROPRIATELY ON MACHINE. IT WAS VARYING FROM 800 - 900 TO 100 - 150. THE I:E RATION ALARM WAS ALSO BLINKING. PT WAS NOT RECEIVING PRESET VOLUME. THIS VENTILATOR WAS CHANGED OUT AND THERE WAS NO INJURY TO THE PT. THIS PIECE OF EQUIPMENT WAS A RENTAL AND THE CO WAS NOTIFIED AND THEY EXCHANGED IT WITH ANOTHER PIECE OF EQUIPMENT OF THE SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR III VOLUME VENTILATOR CBK BEAR MEDICAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention