BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 3772245 · Received April 22, 2014

    Report

    Report Number
    3772245
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE OSCILLATORY VENTILATOR WAS IN USE ON A PATIENT. THE DELTA P WAS FLUCTUATING SIGNIFICANTLY. A DELTA P OF 30 WAS SET, BUT A DELTA P OF 18 WAS MEASURED ON THE DISPLAY. THE PATIENT CIRCUIT WAS CHANGED. THE DELTA P WAS STILL FLUCTUATING FROM 20'S - 30'S. A SIMILAR COMPLAINT ON THIS VENTILATOR HAD OCCURRED ABOUT A YEAR AGO, BUT NO PROBLEM WAS FOUND AT THE TIME. THIS TIME THE PROBLEM WAS REPRODUCED IN CLINICAL ENGINEERING AFTER RUNNING FOR ABOUT AN HOUR. THE FRONT PANEL AMPLITUDE METER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244598 SENSORMEDICS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY