BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 ACORN LH US

    MDR report key: 11382251 · Received February 25, 2021

    Report

    Report Number
    3003124453-2021-00005
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER AND HER SON WERE NOT ABLE TO REMEMBER THE EXACT DATE THEY NOTICED THE SEAT WAS CRACKED. DURING THE 11/28/2020 CALL, THE USER'S SON STATED HIS MOTHER USES HER STAIRLIFT TO CARRY GROCERY BAGS UPSTAIRS. THE STAIRLIFT WAS INSTALLED ON 6/25/2014, AT THAT TIME ACORN DID NOT INFORM CUSTOMERS THE STAIRLIFT SHOULD NOT BE USED AS A DUMBWAITER. IN 2017 THE 130 USER MANUAL WAS REVISED TO INCLUDE THE 'IMPORTANT SAFETY NOTES' SECTION. THIS SECTION INCLUDES A WARNING AGAINST USING THE STAIRLIFT TO TRANSPORT FOOD, ANIMALS, LAUNDRY OR ANY OTHER ITEMS. ON 11/28/2020, THE USER'S SON MENTIONED THAT HE CONTACTED A COMPANY OUT OF (B)(6). WHEN THE STAIRLIFT WAS INSPECTED ON 12/2/2020, THE SERVICE TECHNICIAN OBSERVED NON-ACORN ISSUED BATTERIES WERE BEING USED. ACORN SENT THE SEAT SQUAB TO THE SUPPLIER FOR FURTHER INVESTIGATION. THE SUPPLIER CONCLUDED THE SEAT SQUAB BROKE BECAUSE THE SEAT DESIGN DID NOT PROVIDE ADEQUATE STRENGTH TO SUPPORT CUSTOMER'S WEIGHT WITH CONTINUED USE.

    Description of Event or Problem · 1

    THE USER'S SON CALLED ACORN STAIRLIFTS, INC. (ACORN) ON 11/28/2020 TO REPORT HIS MOTHER'S SEAT SQUAB CRACKED. THE USER WAS SITTING DOWN ON THE SEAT WHEN SHE HEARD A POPPING SOUND AND THE SEAT FELT LIKE IT WAS LEANING FORWARD. THE USER CALLED HER SON WHO EXAMINED THE SEAT AND SAW A CRACK ON THE BOTTOM OF THE SEAT MIDWAY BACK FROM THE FRONT EDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276795 130 ACORN LH US POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR