BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUNO

    MDR report key: 13460512 · Received February 4, 2022

    Report

    Report Number
    2131358-2022-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 5, 2022
    Report Date
    February 4, 2022
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Product Code
    ING
    PMA / PMN Number
    K061514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENT DEALER INFORMED BRUNO OF THE INCIDENT ON 01-05-2022. THE CURRENT DEALER IN (B)(6) IS NOT THE INSTALLING DEALER. THE CURRENT DEALER STARTED SUPPORTING THE UNIT IN (B)(6) 2018. BRUNO CONTACTED THE DEALER ON 01-5-2022 AND ARRANGED TO SEND THE CHIEF ENGINEER FOR THE PRODUCT LINE TO CONDUCT ON-SITE FOR INSPECTION. THIS INSPECTION WAS DELAYED AT END USER'S REQUEST TO LATER IN JANUARY. AT THE SITE, THE CHIEF ENGINEER CONFIRMED WITH THE END USER THAT THERE WERE NO INJURIES AS A RESULT OF THIS INCIDENT. THE INITIAL SITE INVESTIGATION INDICATED THAT THE MAIN DRIVE NUT WAS WORN TO POINT OF FAILURE CAUSING THE PLATFORM TO FALL ON THE SAFETY NUT, AS INTENDED. THE SAFETY SWITCH HOWEVER DID NOT ENGAGED AND THUS ALLOWED THE UNIT TO RIDE ON SAFETY NUT. THE SAFETY NUT THEN FAILED CAUSING THE UNIT TO FAIL. THIS WAS THE FIRST TIME THIS TYPE OF NUT SAFETY SWITCH ENGAGEMENT FAILURE WAS OBSERVED. IT WAS NOT POSSIBLE TO DO A COMPLETE INSPECTION ON SITE. PARTS WERE REMOVED TO CONTINUE THE INVESTIGATION AT THE MANUFACTURER'S FACILITIES. THIS CAPA INVESTIGATION TO DETERMINE ROOT CAUSE IS BEING CONDUCTED UNDER THE OVERSIGHT OF THE DIRECTOR OF ENGINEERING TO DETERMINE REASON(S) THAT MAY HAVE PREVENTED THE SAFETY SWITCH FROM BEING ACTIVATED.

    Description of Event or Problem · 0

    THE EVENT WAS DESCRIBED TO THE MANUFACTURER THIRD HAND WHEN REPORTED ON (B)(6)2022. THE END USER HAS A VPL-3175B (6FT OR 75" TRAVEL) UNIT INSTALLED WITH AN UNENCLOSED EXTERIOR APPLICATION THAT WAS INSTALLED IN 2013. ON (B)(6) 2021, A FRIEND OF THE END USER'S ADULT DAUGHTER WAS OPERATING THE UNIT, STANDING ON THE PLATFORM, WHILE IT ASCENDED. IT WAS REPORTED THAT THE UNIT DROPPED WITHOUT NOTICE. THERE WAS CONFLICTING INFORMATION IF THE RIDER SUFFERED A MINOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798379 BRUNO VERTICAL PLATFORM LIFT ING BRUNO INDEPENDENT LIVING AIDS, INC. VPL-3175B

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female