BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENT AID/HME

    MDR report key: 817601 · Received November 12, 2004

    Report

    Report Number
    8030928-2004-00001
    Event Type
    Other
    Date Received
    November 12, 2004
    Report Date
    November 11, 2004
    Manufacturer
    ICOR/AB
    Product Code
    BYD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HME WAS IN USE ON A PT THAT WAS PRONE TO COPIOUS SECRETIONS (CONTRAINDICATED IN THE PRODUCT LABELING) AND FLOW BECAME RESTRICTED. CAREGIVER ALLEGES THAT THIS CONTRIBUTED TO THE PT SATURATION DECREASING. THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WHILE THE HME WAS IN LINE, WITH SOME IMPROVEMENT IN VITAL SIGNS. PT PLACED BACK ON MECHANICAL VENTILATION, AND VITAL SIGNS DECREASED. THE MANUAL VENTILATION WAS RESTARTED WITH HME STILL IN LINE. A VISUAL EXAMINATION OF THE SET-UP AFTER THE SECOND MANUAL VENTILATION FOUND THE FOAM INSIDE THE HME TO APPEAR DISTORTED, SO THE HME WAS CHANGED. THE REPORT CLAIMS PSYCHOLOGICAL TRAUMA TO THE PT. THE ACTUAL SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AFTER MULTIPLE ATTEMPTS, ALTHOUGH REPORTED AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENT AID/HME HEAT MOISTURE EXCHANGER BYD ICOR/AB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other