BEUDAMED
    FDA Adverse Event Death Summary report: N

    RMA-ICCG BEDS

    MDR report key: 9202689 · Received October 17, 2019

    Report

    Report Number
    1525712-2019-00026
    Event Type
    Death
    Date Received
    October 17, 2019
    Report Date
    September 20, 2019
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED HAS NOT BEEN RETURNED FOR EVALUATION. THE FACILITY WAS CONTACTED AND THEY STATED, THAT THE BED WAS IN THE LOW POSITION, AND LAYING FLAT WHEN THE INCIDENT TOOK PLACE. THE PATIENT WAS FOUND WITH HER HEAD BETWEEN THE MATTRESS AND THE ASSIST RAILS, AND HER HANDS WERE GRIPPING THE RAILS. THE ASSIST RAILS WERE ADDED ON (B)(6) 2019, AT THE REQUEST OF THE DAUGHTER TO HELP WITH THE RESIDENT¿S BED MOBILITY. THE MATTRESS DOES NOT HAVE ANY SAGGING OR BOWING. IT WAS CONFIRMED THAT THE RAILS ON THE BED ARE INVACARE, U BRACKET, ASSIST RAILS, AND THEY ARE MOUNTED CORRECTLY. THE INVACARE BED RAIL USER MANUAL STATES, ON PAGE 2, OF THE ASSIST BAR INSTALLATION PART #1153412-G-00 STATES: "BED ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE. USE OF NON-INVACARE BED ACCESSORIES MAY RESULT IN INJURY OR DEATH. USE ONLY INVACARE RAILS, MATTRESSES, BED EXTENDERS AND OTHER ACCESSORIES WITH INVACARE BED PRODUCTS." HILL-ROM INSPECTED THE MATTRESS AND DID NOT FIND ANY DEFECTS OR MALFUNCTIONS. THE BED AND RAILS HAVE NOT BEEN RETURNED TO INVACARE AT THE TIME OF THIS FILING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE FACILITY ADMINISTRATOR STATED THAT ONE OF HER RESIDENTS WAS USING A SOLO BED FROM 2003. THE END-USER WAS FOUND DECEASED, CAUGHT BETWEEN THE MATTRESS, WHICH IS A HILL-ROM MATTRESS, AND THE INVACARE BED RAILS. THE CORONER INITIALLY STATED THAT THE DEATH WAS DUE TO ACCIDENTAL POSITIONAL ASPHYXIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995802 RMA-ICCG BEDS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE TAYLOR STREET NA:ICCGBEDS

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death