BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL VENTILATOR CIRCUIT WITH NEBULIZER

    MDR report key: 65679 · Received January 31, 1997

    Report

    Report Number
    65679
    Event Type
    Injury
    Date Received
    January 31, 1997
    Date of Event
    January 16, 1997
    Report Date
    January 17, 1997
    Manufacturer
    PROFESSIONAL MEDICAL CIRCUIT WITH NEBULIZER
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BETWEEN THE HRS OF 4 AM AND 8 AM ON 1/16/97, FIVE LONG-TERM VENTILATOR PTS EXPERIENCED PROBLEMS WITH THEIR AIR-FLOW AND SUBSEQUENTLY DEVELOPED RESPIRATORY DISTRESS. AFTER STABILIZATION OF THESE PTS, AN INTERNAL INVESTIGATION WAS STARTED. THE FOLLOWING INFO WAS DISCOVERED: NEW VENTILATOR CIRCUITS WITH NEBULIZER HAD BEEN INSTALLED ON THE VENTS ON 1/12/97. THE LITERATURE THAT ACCOMPANIES THESE CIRCUITS STATES THAT THIS SYSTEM CAN BE USED WITH THE BRAND AND MODEL VENTILATOR THE FACILITY WAS USING. THE VENT CIRCUITS CAME EQUIPPED WITH AN "EXTERNAL EXHALATION VALVE" ATTACHED TO THE TUBING. THE VENTS CURRENTLY IN USE AT THIS MED CTR HAVE AN INTERNAL EXHALATION VALVE ALREADY IN PLACE. THIS IS PT 2 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL VENTILATOR CIRCUIT WITH NEBULIZER VENTILATOR CIRCUIT BZO PROFESSIONAL MEDICAL CIRCUIT WITH NEBULIZER 201-5847 620091

    Patients

    Seq Age Sex Outcome Treatment
    1 *