BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUNO ELECTRA-RIDE

    MDR report key: 332440 · Received May 8, 2001

    Report

    Report Number
    2131358-2001-00001
    Event Type
    Malfunction
    Date Received
    May 8, 2001
    Date of Event
    April 27, 2001
    Report Date
    May 2, 2001
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Product Code
    ILK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL UNIT WAS INSTALLED IN FEB. 1995. IT WAS REMOVED AND REINSTALLED IN THE CUSTOMER'S NEW HOUSE IN JAN. 2000. THE CUSTOMER WAS RIDING THE UNIT DOWN THE STAIRWAY AND HAD MOVED ABOUT A THIRD OF THE WAY DOWN, WHEN THE MAIN DRIVE GEAR WALKED ITSELF OFF THE RAIL GEAR, CAUSING THE STAIRLIFT TO FREE-WHEEL THE REMAINING DISTANCE TO THE BOTTOM OF THE STAIRWAY. WHEN THE STAIRLIFT STOPPED SUDDENLY AT THE BOTTOM OF THE STAIRWAY, THE CUSTOMER WAS NOT WEARING THE SEATBELT PROVIDED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21147 BRUNO ELECTRA-RIDE INCLINED STARIWAY ELEVATOR ILK BRUNO INDEPENDENT LIVING AIDS, INC. SRE-1500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN