BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTHESIA BREATHING CIRCUIT

    MDR report key: 31439 · Received March 25, 1996

    Report

    Report Number
    MW1008714
    Event Type
    Malfunction
    Date Received
    March 25, 1996
    Date of Event
    January 1, 1996
    Report Date
    March 8, 1996
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HYGROSCOPIC CONDENSER HUMIDIFIER (HCH). THE LAST 2 TO 3 CASES OF THIS PRODUCT HAVE HAD "CRACKED" HCH'S. THE CRACK IS COMPLETELY THROUGH THE MASK PORT, CAUSING THE SYSTEM TO HAVE A SEVERE LEAK. ALL HCH'S WERE DISCOVERED PRIOR TO USE DURING PREOPERATIVE CHECK OF ANESTHESIA MACHINE AND EQUIPMENT. CO NOTIFIED 3/8/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT CAI VITAL SIGNS, INC. 2265

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other