BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT FILTER HYDROSCOPIC CONDENSOR HUMIDIFIER

    MDR report key: 170531 · Received May 27, 1998

    Report

    Report Number
    8030928-1998-00001
    Event Type
    Death
    Date Received
    May 27, 1998
    Date of Event
    April 19, 1998
    Report Date
    May 26, 1998
    Manufacturer
    ICOR AB
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    FILTER HCH ANALYSIS. THE MED PRODUCTS AGENCY IN SWEDEN HAS MADE A CHEMICAL ANALYSIS OF THE FILTER HCH FROM THE REPORTED ADVERSE EVENT. THE ANALYSIS WAS MADE OF THE FILTER-AND FOAM PART OF THE FILTER HCH. IDENTICAL FILTER HCH WAS A REFERENT. THE ANALYSIS RESULT. THE ACTIVE PART OF THE DRUG VENTOLIN-SALBUTAMOL WAS FOUND IN THE FILTER AND THE FOAM. SALBUTAMOL WAS IDENTIFIED AND VERIFIED BY NMR. THE TOTAL AMOUNT OF SALBUTAMOL WAS ABOUT 15 MG (12,2 MG IN THE FILTER AND 2,6 MG IN THE FOAM). CONCLUSION. THIS CONFIRM INCORRECT USE OF FILTER HCH, AGAINST INSTRUCTION FOR USE, DURING NEBULISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT FILTER HYDROSCOPIC CONDENSOR HUMIDIFIER FILTER HCH BYD ICOR AB 003005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death LIFECARE PLV-102 VENTILATOR ADULT CIRCUIT 001765.