BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3190345 · Received June 18, 2013

    Report

    Report Number
    3190345
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST WAS ADMINISTERING RESPIRATORY THERAPY WITH A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) NON-INVASIVE VENTILATOR THAT WAS CONNECTED TO THE PATIENT VIA CIRCUIT TUBING AND MASK. THE MASK CAME LOOSE FROM THE CIRCUIT TUBING CAUSING THE PATIENT TO DESATURATE TO 81%.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NONINVASIVE VENTILATION (NIV) REFERS TO THE ADMINISTRATION OF VENTILATORY SUPPORT WITHOUT USING AN INVASIVE ARTIFICIAL AIRWAY (ENDOTRACHEAL TUBE OR TRACHEOSTOMY TUBE). THE USE OF NONINVASIVE VENTILATION HAS MARKEDLY INCREASED OVER THE PAST TWO DECADES, AND NONINVASIVE VENTILATION HAS NOW BECOME AN INTEGRAL TOOL IN THE MANAGEMENT OF BOTH ACUTE AND CHRONIC RESPIRATORY FAILURE, IN THE CRITICAL CARE UNIT. NONINVASIVE VENTILATION HAS BEEN USED AS A REPLACEMENT FOR INVASIVE VENTILATION, BUT ITS FLEXIBILITY ALSO ALLOWS IT TO BE A VALUABLE COMPLEMENT IN PATIENT MANAGEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276916 * VENTILATOR CBK RESPIRONICS INC. AF531 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR