BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEBULIZER

    MDR report key: 67319 · Received February 7, 1997

    Report

    Report Number
    MW1010687
    Event Type
    Death
    Date Received
    February 7, 1997
    Date of Event
    January 25, 1997
    Report Date
    February 3, 1997
    Manufacturer
    HEALTHDYNE, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED TO THE CERTIFIED HOME HEALTH AGENCY, A FIRE OCCURRED IN THE PT'S HOME IN THE EARLY MORNING HRS OF 1/25/97. THE CAUSE OF THE FIRE IS UNKNOWN AS IS THE EXACT LOCATION OF THE START OF THE FIRE. THE PT WAS ON A RESPIRATOR. PT EXPIRED AT THE HOSP WHERE THEY WERE IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZER NEBULIZER CAF HEALTHDYNE, INC. X5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death