BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVILBISS

    MDR report key: 359936 · Received November 8, 2001

    Report

    Report Number
    MW4003131
    Event Type
    Injury
    Date Received
    November 8, 2001
    Date of Event
    August 25, 2001
    Report Date
    November 8, 2001
    Manufacturer
    SUNRISE MEDICAL HHG, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT DIED OF HEART ATTACK/BURNS CAUSED BY A NEBULIZER WHICH IGNITED AND BURNED THEIR HOME. FIRE WAS INVESTIGATED BY FIRE DEPT. RPTR STATED THAT THE FIRE STARTED AT THE JUNCTION OF THE NEBULIZER AC CORD AND ON/OFF SWITCH. LAWSUIT INITIATED AGAINST MFR. FAMILY MEMBER RECENTLY VISITED HOME OF ONE OF THEIR STUDENTS AND NOTED ANOTHER MODEL 3650D DEVILBISS NEBULIZER WHICH HAD ELECTRICAL INSULATION DAMAGE (BUBBLING) ON THE AC POWER CORD AS IT ENTERED VAPORIZER. THIS DAMAGED AREA HAD BEEN COVERED WITH ELECTRICAL TAPE BY THE USER. RPTR STATED THAT PT EITHER HAD ALREADY OBTAINED THIS UNIT IN SUPPORT OF LAWSUIT OR WILL SHORTLY HAVE IT IN POSSESSION. THE NEBULIZER WAS RECEIVED/OWNED BY HOME HEALTH CO. THERE ARE NO RECALLS LISTED FOR THIS MODEL. THIS DEVICE WAS CLEARED ON 4/15/97 UNDER K970289. RPTR STATED THAT BASED ON DEATH CERTIFICATE THAT USER EXPERIENCED FATAL HEART ATTACK BECAUSE OF FIRE SINCE ONLY A SMALL AMOUNT OF CARBON MONOXIDE WAS FOUND AT AUTOPSY OF USER'S SEVERELY BURNED BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49950 DEVILBISS NEBULIZER CAF SUNRISE MEDICAL HHG, INC. 3650D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO