BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSVENT 3

    MDR report key: 2182957 · Received July 22, 2011

    Report

    Report Number
    2182957
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CROSSVENT 3 VENTILATOR BEGAN TO GIVE INTERMITTENT POSITIVE END EXPIRATORY PRESSURE (PEEP) READINGS OF 0, EXHALED TIDAL VOLUMES OF 0 AND THEN VERY HIGH EXHALED TIDAL VOLUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSVENT 3 VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR