BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2000 OUTDOOR

    MDR report key: 7443160 · Received April 19, 2018

    Report

    Report Number
    3011268530-2018-00016
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    March 21, 2018
    Report Date
    April 19, 2018
    Manufacturer
    HANDICARE
    Product Code
    PCD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HANDICARE ACCESSIBILITY (B)(6), THE MANUFACTURER OF 2000 SERIES OUTDOOR, SN (B)(4) HAS COMPLETED THEIR INVESTIGATION INTO THE INCIDENT. THE MANUFACTURER HAS PERFORMED A FULL REVIEW OF THE PICTURES PROVIDED FROM THE INSTALLATION AS WELL AS DISASSEMBLY OF THE POWER PACK FOR INSPECTION OF INTERNAL COMPONENTS. IN ADDITION, THE TRUNNION CASTING WAS SENT FOR EXTERNAL MATERIAL ANALYSIS BY A METALLURGICAL LABORATORY. THEIR CONCLUSION IS THAT THE PACK WAS MISLOADED DURING INSTALLATION AND SUBSEQUENT REINSTALLATION. THE RESULTING MISALIGNMENT AND EXCESSIVE FORCES OVER TIME CAUSED A STRESS FRACTURE OF THE TRUNNION CASTING, RESULTING IN THE INCIDENT. THEY ALSO NOTED THAT BECAUSE THE INSTALLATION CONTAINS NO HORIZONTAL RAIL SEGMENTS GREAT CARE WOULD BE NEEDED ON THE PART OF THE INSTALLER TO AVOID A MISALIGNMENT. DEALER AND INSTALLER ARE COMMUNICATED TO REINFORCE THE IMPORTANCE OF MAKING SURE THAT THE PACK IS CORRECTLY LOADED AS DESCRIBED IN THE INSTALLATION MANUALS.

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIGATION IS PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    AN END USER WAS SITTING IN THE CHAIR SEAT OF A 2000 OUTDOOR STAIRLIFT AND WHILE IN MOTION, THE CHAIR SEAT BROKE AWAY FROM THE RAIL. THE END USER TUMBLED DOWN THE STAIRWAY. FOLLOWING THE FALL HE HAD A GASH ON HIS HEAD, HURT HIS ARM, AND HIS LEGS. HE WENT TO AN URGENT CARE FACILITY FOR ATTENTION. HE WAS TREATED FOR HIS INJURIES AND WAS HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285511 2000 OUTDOOR OUTDOOR STAIRLIFT PCD HANDICARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization