BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 2110521 · Received May 25, 2011

    Report

    Report Number
    2110521
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 18, 2009
    Report Date
    May 19, 2009
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST COULD NOT ADJUST THE OSCILLATORY VENTILATOR'S MEAN PRESSURE LIMIT DUE TO THE CONTROL KNOB GOING PAST THE MECHANICAL STOP. THERAPIST COULD NOT CALIBRATE THE PATIENT CIRCUIT DUE TO THE CONTROL KNOB FAILURE. VENTILATOR WAS EXCHANGED AND THE NEW ONE WAS CALIBRATED AND THERAPY CONTINUED. THIS IS A VOLUNTARY REPORT AS THIS IS THE SECOND OCCURRENCE OF THIS TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 207, INC. 3100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *