BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTERIAL/ VIRAL FILTER WESTMED

    MDR report key: 10406980 · Received August 14, 2020

    Report

    Report Number
    10406980
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 6, 2020
    Manufacturer
    WESTMED INC.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BACTERIAL/VIRAL FILTER CONNECTED TO THE ANESTHESIA BREATHING CIRCUIT SEPARATED. THIS IS NOT THE FIRST REPORT ON THESE FILTERS. HAPPENING AT ANOTHER HOSPITAL IN OUR SYSTEM ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873127 BACTERIAL/ VIRAL FILTER WESTMED FILTER, BACTERIAL, BREATHING-CIRCUIT CAH WESTMED INC.

    Patients

    Seq Age Sex Outcome Treatment
    1