BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE STAIRLIFT

    MDR report key: 24537763 · Received March 6, 2026

    Report

    Report Number
    3004153586-2026-00002
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    October 7, 2025
    Report Date
    March 6, 2026
    Manufacturer
    HARMAR MOBILITY LLC
    Product Code
    PCD
    UDI-DI
    00817650026188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PINNACLE SL300 WAS NOT RETURNED FOR EVALUATION. THE INFORMATION CURRENTLY AVAILABLE TO HARMAR IS THAT THE UNIT WAS ORIGINALLY INSTALLED BY ONE DEALER ON (B)(6) 2025 AND WAS IN USE FOR 6 MONTHS BY THE ORIGINAL OWNER. IT WAS THEN UNINSTALLED SOMETIME ON (B)(6) 2025 AND RE-INSTALLED BY A SECOND DEALER AT A DIFFERENT RESIDENCE WHERE THE IMPACTED END USER RESIDED. BASED ON CURRENTLY AVAILABLE INFORMATION, IT IS UNCLEAR WHAT MAY HAVE CAUSED THE DEVICE TO SUDDENLY DESCEND DURING OPERATION AS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY THE MANUFACTURER OR FDA THAT THE MANUFACTURER OR ITS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE END USER WAS RIDING THE PINNACLE SL300 UP THE STAIRS, THE CHAIR DESCENDED ABRUPTLY NEAR THE TOP OF THE STAIRCASE, THRUSTING THE USER ONTO THE FLOOR. IT WAS ALSO REPORTED THAT THE END USER EXPERIENCED HUMERAL, RIB, AND ANKLE FRACTURES AND A DEGLOVED LOWER RIGHT LEG REQUIRING HOSPITALIZATION AND HAD SURGERY TO REDUCE THE ANKLE FRACTURE. THE REPORTER STATED THAT THE SL300 WAS INSTALLED AT THE END USER'S RESIDENCE ON (B)(6) 2025, AND THE EVENT HAPPENED APPROXIMATELY 30 MINUTES AFTER THE INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607181 PINNACLE STAIRLIFT POWERED STAIRWAY CHAIR LIFT PCD HARMAR MOBILITY LLC SL300 00817650026188

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| S