BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2001745 · Received February 21, 2011

    Report

    Report Number
    1525712-2011-00058
    Event Type
    Death
    Date Received
    February 21, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 18, 2011
    Manufacturer
    INVACARE CORP.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE RECEIVED INFO ALLEGING A FIRE HAD OCCURRED RESULTING IN A CONSUMER'S DEATH. THE DEALER ADVISED THAT A NON INVACARE GEL MATTRESS WAS ON THE BED, AND THE CONSUMER WAS A KNOWN SMOKER. THE DEALER WAS UNABLE TO CONFIRM THE MODEL NUMBER OR SERIAL NUMBER OF THE BED THAT IS INVOLVED IN THE ALLEGED INCIDENT. A FIRE INVESTIGATOR PROVIDED A SERIAL NUMBER FROM THE FRAME OF THE BED THAT WAS NOT IDENTIFIABLE. SOME PHOTOS WERE PROVIDED AND NO DETERMINATION COULD BE MADE. INVACARE IS WORKING TO SCHEDULE A 3RD PARTY FIRE INVESTIGATOR FOR INSPECTION OF THE BED. IT HAS NOT BEEN CONFIRMED AN INVACARE BED AT THIS TIME.

    Description of Event or Problem · 1

    MFR RECEIVED INFO, A CONSUMER WAS IN A BED WHEN AN ALLEGED FIRE OCCURRED, RESULTING IN THE CONSUMER'S DEATH. THE CAUSE OF THE FIRE HAS NOT BEEN DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R