BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3747025 · Received April 11, 2014

    Report

    Report Number
    1031452-2014-00889
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED BY AN INSURANCE AGENCY THAT A FIRE HAD OCCURRED AT THE HOME OF ONE OF THEIR CUSTOMERS. IN ADDITION, IT WAS REPORTED THE CUSTOMER HAD AN AC-POWERED ADJUSTABLE HOSPITAL BED, MANUFACTURED BY INVACARE (MODEL: 5410LOW) IN THE HOME. UPON ARRIVING, THE FIRE FIGHTERS NOTED NINE NON-INVACARE OXYGEN CYLINDERS AT THE BACK OF THE HOUSE. BEFORE THE FIRE FIGHTERS COULD EVACUATE THE AREA, THE CYLINDERS EXPLODED, INJURING THREE OF THEM. (B)(6), FEMALE OCCUPANT OF THE HOME REPORTEDLY PERISHED IN THE FIRE; WHILE THE MALE OCCUPANT (AGE UNKNOWN) SUSTAINED BURNS. THE DESCENDANT WAS REPORTEDLY NOT IN THE AREA OF ORIGIN OF THE FIRE AT THE TIME OF IGNITION. DUE TO HER PHYSICAL STATE/CONDITION, SHE WAS UNABLE TO ACT OR EXIT THE BUILDING. THE MALE OCCUPANT HAS SINCE PASSED AWAY. NO CAUSE OF DEATH WAS PROVIDED. ACCORDING TO THE INCIDENT REPORT DRAFTED BY THE (B)(6) FIRE PROTECTION DISTRICT, THE ORIGIN OF THE FIRE WAS DETERMINED TO BE THE BEDROOM. THE CAUSE IS UNDETERMINED AT THIS TIME. THE INVESTIGATION INTO THE FIRE IS ON-GOING; HOWEVER, THERE IS NO ALLEGATION THE FIRE WAS IGNITED BY THE AC-POWERED ADJUSTABLE HOSPITAL BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221332 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R