BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 ACORN LH US HEAVY DUTY

    MDR report key: 11338977 · Received February 17, 2021

    Report

    Report Number
    3003124453-2021-00003
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Report Date
    February 17, 2021
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DATE AND THE DATE OF THE EVENT ARE UNKNOWN. AN ACORN DEALER, THROUGH THE VA, INSTALLED THE STAIRLIFT FIVE YEARS AGO FOR THE CUSTOMER'S HUSBAND, BUT IN THE PAST FEW YEARS, SHE STARTED USING THE STAIRLIFT. IN MARCH, THE CUSTOMER CONTACTED THE DEALER TO REPLACE HER BROKEN SEAT; HOWEVER, THE DEALER WAS NOT ABLE TO REPAIR THE STAIRLIFT. 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 CUSTOMER CONTACTED ACORN STAIRLIFTS, INC. (ACORN) ON 6/30/2020 REQUESTING SERVICE TO REPLACE HER BROKEN SEAT SQUAB. AT THE END OF (B)(6), SHE WAS SITTING ON THE EDGE OF THE SEAT TRYING TO GET OFF AT THE BOTTOM OF THE STAIRS WHEN THE SEAT SQUAB SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233088 130 ACORN LH US HEAVY DUTY POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1