BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUNO

    MDR report key: 10660082 · Received October 11, 2020

    Report

    Report Number
    2131358-2018-00002
    Event Type
    Malfunction
    Date Received
    October 11, 2020
    Date of Event
    February 16, 2018
    Report Date
    March 19, 2018
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Product Code
    ING
    PMA / PMN Number
    K061514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SENT CHIEF ENGINEER FOR THE PRODUCT LINE TO INSPECT UNIT IN FIELD, FOUND THAT THE ACCIDENT SITE CONDITION HAD BEEN COMPROMISED SINCE THE ORIGINAL ACCIDENT CONDITION. DISCOVERY SHOWED THAT THE SAFETY SYSTEM HAD BEEN BYPASSED ALLOWING THE LIFT TO RUN. BACKUP FAILURE CAUSED THE UNIT TO DROP. BASED ON DISCUSSIONS AT SITE WITH DEALER, SUSPECT THIS BYPASS OF SAFETY SYSTEM OCCURRED WHEN DEALER SERVICED THE UNIT IN APRIL 2017 (10 MONTHS BEFORE THE ACCIDENT). AFTER LOCKING OUT THE EQUIPMENT, ACCESS TO THE SAFETY CIRCUIT IS ONLY GAINED BY USING TOOLS TO REMOVE LARGE TOWER ACCESS PANELS. THEN THE DRIVE NUT SAFETY CIRCUITRY WAS BYPASSED WITH A HARNESS. MAINTENANCE OF THE EQUIPMENT AND THE CIRCUITRY IS GONE OVER IN DETAIL DURING REQUIRED DEALER TRAINING. THE ABILITY TO BYPASS THE DRIVE SAFETY CIRCUITRY IS REQUIRED IN THE EVENT OF FAILURE TO ALLOW FIRST RESPONDERS TO USE THE SAFETY NUT FOR A ONE WAY TRIP SAFELY LOWER THE PLATFORM TO LOWER LANDING AND THEN "LOCK OUT" SYSTEM UNTIL PARTS CAN BE REPLACED.

    Description of Event or Problem · 1

    UNIT PLATFORM DROPPED AND PERSON INJURED. THE PLATFORM DROPPED DUE TO THE FAILURE OF THE DRIVE NUT AND SAFETY NUT. UNLESS TAMPERED WITH, IF THE DRIVE NUT FAILS THE SAFETY SWITCH IS ENGAGED TO PREVENT THE UNIT FROM RUNNING WHILE THE PLATFORM SECURELY RESTS ON THE SAFETY NUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124928 BRUNO VERTICAL PLATFORM LIFT ING BRUNO INDEPENDENT LIVING AIDS, INC. VPL-3175

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization