BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 1609350 · Received February 11, 2010

    Report

    Report Number
    1525712-2010-00018
    Event Type
    Death
    Date Received
    February 11, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 11, 2010
    Manufacturer
    INVACARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED INFORMATION THAT INDICATES A HOME CARE FACILITY HAD DISCOVERED PT OVER THE EDGE OF HIS BED FACE DOWN ON THE MATTRESS. ZONE OF ENTRAPMENT APPEARS TO BE ZONE 3. PICTURES PROVIDED INDICATE THE RAIL WAS IN THE ASSIST POSITION. THE BED SYSTEM IN USE DOES NOT APPEAR TO HAVE BEEN EQUIPPED WITH AN INVACARE MATTRESS. PT WAS FOUND BREATHING, AND TRANSPORTED TO A HOSPITAL WHERE THEY LATER PASSED. NO ALLEGED PRODUCT MALFUNCTION. MDR FILED BASED ON DEATH.

    Description of Event or Problem · 1

    THE CONSUMER WAS ALLEGEDLY FOUND WITH HIS HEAD RESTING AGAINST THE RAIL AND FACE DOWN ON THE MATTRESS WITH HIS LOWER BODY ON THE FLOOR. THE CONSUMER WAS TAKEN TO THE HOSPITAL WHERE HE LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE ARRO 171

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| R