BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE STAIRLIFT

    MDR report key: 22877859 · Received August 22, 2025

    Report

    Report Number
    3004153586-2025-00002
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    June 8, 2023
    Report Date
    August 22, 2025
    Manufacturer
    HARMAR MOBILITY LLC
    Product Code
    PCD
    UDI-DI
    00817650022944
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL INVESTIGATION OF THIS EVENT CONDUCTED IN JUNE 2023 CONCLUDED THAT THE DEVICE OPERATED AS EXPECTED AND THE ISSUE WAS UNINTENTIONALLY CAUSED BY THE END USER. IN CONNECTION WITH A SUBSEQUENT LEGAL CLAIM, A PRELIMINARY INSPECTION OF THE DEVICE WITH COUNSEL FOR BOTH PARTIES PRESENT WAS CONDUCTED IN OCTOBER 2024 IN THE HOME WHERE THE REPORTED EVENT TOOK PLACE. DURING THE INSPECTION, CERTAIN PORTIONS OF THE SAFETY PAN NEAR THE FRONT OF FOOTREST DID NOT APPEAR TO REGISTER CONTACT. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED, SO HARMAR MOBILITY, LLC (HARMAR) HAS NOT BEEN ABLE TO CONDUCT A FULL TECHNICAL EVALUATION OF THE UNIT AND IDENTIFY A DEFINITIVE CAUSE OF THIS ISSUE. THE DEVICE HISTORY RECORD FOR THE STAIRLIFT UNIT INVOLVED WAS REVIEWED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THERE WERE NO REPORTS TO HARMAR OF FOOTREST PROBLEMS AT THE TIME OF INSTALLATION OR SHIPPING DAMAGE FOR THIS UNIT, AND NO RECORDS FROM HARMAR SUPPLIERS OF MANUFACTURING OR QUALITY ISSUES DURING THE PERIOD THAT THE UNIT WAS MANUFACTURED. A REVIEW OF HISTORICAL COMPLAINT INFORMATION DATING BACK TO 2018 DID NOT IDENTIFY TRENDS POINTING TO A MANUFACTURING OR DESIGN ISSUE INVOLVING THE FOOTREST SAFETY PAN, AND THE 8 COMPLAINTS RECEIVED BETWEEN 2018 AND JULY 2025 INVOLVING THE FOOTREST SAFETY PAN REPRESENTED 0.014% OF PINNACLE SL300 STAIRLIFTS SOLD DURING THE SAME TIME PERIOD. THE SL300 STAIRLIFTS HAVE ADDITIONAL SAFETY MECHANISMS IN PLACE TO DETECT AND MITIGATE RISK RELATED TO ISSUES WITH THE SAFETY PAN, INCLUDING INSTRUCTIONS FOR ALL DEVICE INSTALLERS TO CONDUCT SAFETY TESTING OF THE FOOTREST. THE DEVICE INSTALLATION AND SERVICE MANUAL INSTRUCTS INSTALLERS TO IMMEDIATELY CALL THE MANUFACTURER FOR ASSISTANCE IN DIAGNOSING AND REPAIRING THE PROBLEM IF ANY SAFETY STOP SWITCH FAILS TO IMMEDIATELY STOP THE LIFT. HARMAR WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS INVOLVING THE FOOTREST SAFETY PAN AND TAKE FURTHER ACTION IF APPROPRIATE. 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

    ON (B)(6) 2023, IT WAS REPORTED THAT THE DEVICE USER WAS GOING DOWNSTAIRS AND FOOT CAUGHT BETWEEN FOOTPLATE AND STAIR, THE USER WAS INJURED AND RUSHED TO HOSPITAL, AND THE USER'S GRANDDAUGHTER SAID THE USER'S FEET WERE NOT ON THE PLATE WHEN THE UNIT WAS GOING DOWN. FOLLOW-UP INFORMATION OBTAINED FROM THE STAIRLIFT DEALER INDICATED THAT USER'S GRANDDAUGHTER TOLD HIM THAT WHEN THE USER GOT TO THE BOTTOM OF THE STEPS, THE USER WENT TO GET OFF THE LIFT AND SHE HIT THE TOGGLE SWITCH, CAUSING THE LIFT TO GO UP AND CUT INTO HER LEG. THE DEALER INDICATED THAT THE LIFT WAS WORKING AS IT IS DESIGNED TO WORK AND THAT THE USER WAS TAKEN TO TRAUMA SURGERY AND THEY PLANNED TO DO A WOUND VAC. THE DEALER ALSO REPORTED THAT THE USER WAS GOING TO HAVE SKIN GRAFTS AND THAT HIS TECH RAN FUNCTIONAL TESTS AND THE LIFT WAS WORKING AS DESIGNED. IT WAS LATER ALLEGED IN CONNECTION WITH A LEGAL CLAIM THAT THE STAIRLIFT FOOTREST FAILED TO DETECT OBSTRUCTIONS ON THE FRONT FOOTPLATE. IT WAS ALSO ALLEGED THAT, AS A RESULT OF THIS INCIDENT, THE USER SUSTAINED SIGNIFICANT PERMANENT INJURIES, AND HAS CONTINUOUS LEG PAIN AND DIFFICULTY WALKING. ADDITIONAL INFORMATION OBTAINED IN CONNECTION WITH THE LEGAL CLAIM INDICATED THAT THE USER REMAINED IN THE HOSPITAL FOR APPROXIMATELY A WEEK AFTER THE INCIDENT AND THEN RECEIVED TREATMENT AT A REHAB FACILITY AND WOUND CARE BEFORE RETURNING HOME. AFTER LEAVING THE REHAB FACILITY, THE USER ALSO RECEIVED IN-HOME PHYSICAL THERAPY AND SAW ADDITIONAL PHYSICIANS, AND THE USER'S WOUNDS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503913 PINNACLE STAIRLIFT POWERED STAIRWAY CHAIR LIFT PCD HARMAR MOBILITY LLC SL300 00817650022944

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| S