BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

    MDR report key: 9888534 · Received March 27, 2020

    Report

    Report Number
    9888534
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    August 8, 2019
    Report Date
    March 13, 2020
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF CALLED TO PATIENT'S ROOM FOR ACT. PATIENT IN RESPIRATORY DISTRESS, GASPING, INCREASED O2 CONSUMPTION FROM 3 TO 9 LITERS PER MINUTE. ATTEMPTED TO PLACE ON NIV, HOWEVER WAS UNABLE TO REMOVE CLEAR VENTED ELBOW TO REPLACE THE BLUE UNVENTED ELBOW CAUSING APPROXIMATELY A TEN MINUTE DELAY IN PLACEMENT OF PATIENT ON NIV. PATIENT IMPROVED AFTER APPROXIMATELY TEN MINUTES ON NIV RR 23 UNLABORED, ON NIV, ALERT -- RESPONDING TO NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351035 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 190212

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA