BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGHLANDER

    MDR report key: 22755213 · Received August 8, 2025

    Report

    Report Number
    3004153586-2025-00001
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 10, 2025
    Manufacturer
    HARMAR MOBILITY LLC
    Product Code
    PCE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HARMAR RECEIVED THE RETURNED VPL UNIT ON AUGUST 11, 2025, AND A NEW UNIT WAS SHIPPED TO REPLACE THE REMOVED UNIT. ON THE VPL UNIT INVOLVED IN THIS EVENT, THE UPPER GATE LANDING HAD BEEN REMOVED, AND THE INTERLOCK MECHANISM HAD BEEN MODIFIED, ALLOWING THE UNIT TO BE OPERATED WITHOUT THE UPPER LANDING GATE IN PLACE. BASED ON HARMAR'S INSPECTION OF THE UNIT AND INFORMATION FROM THE DEALER, IT APPEARS THAT THE USER HAD BEEN OPERATING THE UNIT IMPROPERLY WITH THESE MODIFICATIONS. HARMAR'S PHYSICAL INSPECTION NOTED THE FOLLOWING: DEFORMATION ON THE UPPER LIMIT SWITCH MOUNTING BRACKET AND CHANNEL, WHICH WOULD HAVE CAUSED THE UPPER LANDING GATE NOT TO UNLOCK; DAMAGE TO THE CARRIAGE SUPPORT BRACKET AND TOWER TOP PLATE SHOWING EVIDENCE THAT THE PLATFORM AND CARRIAGE DROVE INTO THE TOP CAP OF THE TOWER SECTION; EVIDENCE OF DAMAGE FROM THE CARRIAGE DRIVE NUT BEING FORCED THROUGH THE CARRIAGE SUPPORT BRACKET; SIGNS OF DAMAGE TO THE TRAILING CABLE; AND NO RECORDED MAINTENANCE ON THE UNIT'S TOWER DECAL. A SEARCH OF HARMAR'S SALESFORCE RECORDS ALSO FOUND NO EVIDENCE OF MAINTENANCE BEING CONDUCTED ON THE UNIT SINCE IT WAS ORIGINALLY INSTALLED IN 2021. THERE WERE NO ISSUES NOTED IN THE DEVICE HISTORY RECORD AND NO PRIOR COMPLAINTS IN HARMAR'S COMPLAINTS SYSTEM FOR THIS UNIT. HARMAR'S INSTALLATION & SERVICE MANUAL FOR THIS PRODUCT INSTRUCTS INSTALLERS TO CHECK ALL THE INTERLOCKS OF THE UNIT DURING MAINTENANCE SERVICE VISITS TO ENSURE THAT THE INTERLOCKS ARE OPERATING. REGULAR MAINTENANCE SHOULD HAVE DETECTED THE ISSUES WITH THE UPPER LIMIT SWITCH OBSERVED IN HARMAR'S PHYSICAL EXAMINATION OF THE UNIT. HARMAR HAS SHIPPED OVER 6,200 VPL2.0 UNITS SINCE APRIL 2020 AND BASED ON THE COMPANY'S COMPLAINT RECORDS, THIS IS THE FIRST REPORTED INCIDENT OF AN UNCONTROLLED CARRIAGE DESCENT. THIS IS ALSO THE FIRST REPORT OF A VPL IN OPERATION WITH THE UPPER LANDING DOOR BEING REMOVED AND THE UPPER LANDING INTERLOCK DEFEATED BY THE END USER. IT IS CURRENTLY UNKNOWN IF THE USER MADE OTHER CHANGES THAT COULD HAVE AFFECTED THE OPERATION OF THE LIFT. THE COMPANY'S INVESTIGATION IS ONGOING. 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 7/11/2025, HARMAR BECAME AWARE OF AN EVENT RELATED TO THE VPL DEVICE S/N: (B)(6). DURING THE MAINTENANCE OF THE REFERENCED VERTICAL PLATFORM LIFT, THE INSTALLER CALLED HARMAR AND INDICATED THAT HE WAS MADE AWARE OF THE END USER RIDING IN THE VPL CARRIAGE FROM THE GROUND UP TO THE DECK WHEN THE CARRIAGE PASSED THE UPPER LANDING. THE INSTALLER CLAIMED THAT THE END USER WAS IN THE VPL CARRIAGE AS IT DESCENDED ABOUT 3.5 FEET TO THE GROUND. THE END USER RIDING THE VPL CARRIAGE WAS NOT INJURED. WHILE ON SITE, THE CERTIFIED INSTALLER DISCONNECTED THE POWER FROM THE UNIT, PLACING THE UNIT OUT OF SERVICE. THERE IS NO PREVIOUS SERVICE HISTORY ON THE UNIT. THE UNIT WAS INSTALLED IN 2021 AND WAS SAFELY REMOVED FROM THE RESIDENCE ON 7/31/2025.

    Description of Event or Problem · 0

    ON 7/11/2025 HARMAR BECAME AWARE OF AN EVENT RELATED TO THE VPL DEVICE S/N (B)(6). DURING THE MAINTENANCE OF THE REFERENCED VERTICAL PLATFORM LIFT, THE INSTALLER CALLED HARMAR AND REPORTED THAT THE END USER WAS RIDING IN THE VPL CARRIAGE FROM THE GROUND UP TO THE DECK WHEN THE CARRIAGE PAST THE UPPER LANDING. THE END USER THEN PROCEEDS TO GO DOWN WHILE IN THE VPL CARRIAGE AS IT DESCENDS ABOUT 3.5 FEET TO THE GROUND. HARMAR APPROVED INSTALLER DISCONNECTED THE POWER FROM THE UNIT PLACING THE UNIT OUT OF SERVICE. THERE IS NO PREVIOUS SERVICE HISTORY ON THE UNIT. THE UNIT WAS INSTALLED IN 2021 AND WAS SAFELY REMOVED FROM THE RESIDENCE ON 7/31/2025 TO BE RETURNED TO HARMAR FOR EVALUATION. THE END USER RIDING THE VPL CARRIAGE WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914038 HIGHLANDER VPL 2.0 4FT PCE HARMAR MOBILITY LLC HIGHLANDER II

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female