BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3611269 · Received February 6, 2014

    Report

    Report Number
    1031452-2014-00256
    Event Type
    Death
    Date Received
    February 6, 2014
    Date of Event
    January 19, 2014
    Report Date
    January 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BED WAS INVOLVED IN A HOUSE FIRE. THE FEMALE CONSUMER PASSED AWAY DURING THE INCIDENT AND THE MALE CONSUMER SUSTAINED UNSPECIFIED BURNS. THE MALE CONSUMER RECEIVED UNSPECIFIED MEDICAL INTERVENTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BED WAS INVOLVED IN A HOUSE FIRE. THE FEMALE CONSUMER PASSED AWAY DURING THE INCIDENT AND THE MALE CONSUMER SUSTAIN UNSPECIFIED BURNS. THE MALE CONSUMER RECEIVED UNSPECIFIED MEDICAL INTERVENTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION: ON (B)(4) 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. AN (B)(6)-YEAR-OLD, 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), 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
    78130 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410LOW

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| L| R