BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUNO INDEPENDENT LIVING AIDS, INC

    MDR report key: 12124905 · Received July 6, 2021

    Report

    Report Number
    2131358-2021-00002
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC
    Product Code
    ING
    PMA / PMN Number
    K061514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DISTRIBUTOR WHO SPOKE WITH THE END USER, THE USER WAS RIDING THE UNIT UP FROM THE LOWER LANDING LEVEL, THE UNIT MADE A LOUD NOISE AND THEN DROPPED 3 TO 4 FEET TO THE GROUND/LOWER LANDING LEVEL. THE USER SUFFERED NO INJURIES. BRUNO SENT THE CHIEF ENGINEER ON THE PRODUCT LINE TO REVIEW THE UNIT'S CONDITION. THE CHIEF ENGINEER FOUND THAT THE MAIN DRIVE NUT HAD WORN TO THE POINT WHERE THE PLATFORM FELL ONTO THE SAFETY NUT AS DESIGNED. THE CONDITION OF THE SAFETY NUT SWITCH HOWEVER SHOWED A BRACKET THAT WAS LOOSE AND OUT OF POSITION. THIS PREVENTED THE SAFETY NUT SWITCH FROM DISCONNECTING POWER TO THE DRIVE AND STOPPING THE UNIT FROM RUNNING. SINCE THE SAFETY NUT SWITCH WAS NOT ACTIVATED, THE UNIT RAN ON THE SAFETY NUT FOR AN UNKNOWN PERIOD OF TIME UNTIL THE SAFETY NUT FAILED CAUSING THE PLATFORM TO FALL. THE UNIT HAD MAINTENANCE PERFORMED BY THE DISTRIBUTOR APPROXIMATELY A FEW MONTHS BEFORE THE INCIDENT, WHICH INCLUDED CLEANING AND GREASING THE ACME SCREW. DURING THAT MAINTENANCE, THE DISTRIBUTOR SHOULD HAVE CHECKED THE CONDITION OF ALL SAFETY SYSTEMS INCLUDING THE DRIVE NUTS IN ACCORDANCE WITH MANUFACTURER'S WRITTEN GUIDANCE AND TRAINING. FURTHERMORE, THE MAINTENANCE PERFORMED BY THE DISTRIBUTOR WOULD HAVE MADE VISIBLE THE CONDITION OF THE SAFETY NUT SWITCH AND SAFETY NUT AND THE UNIT'S NEED FOR ADDITIONAL SERVICE AND REPLACEMENT PARTS. PRIOR TO THE INCIDENT, MAINTENANCE WAS NOT PERFORMED ACCORDING TO MANUFACTURER'S DIRECTION. THE MANUFACTURER RECOMMENDS MAINTENANCE BE PERFORMED ON THE UNIT ON AN ANNUAL BASIS. INSTEAD, THE USER HAD MAINTENANCE PERFORMED ONLY WHEN THE UNIT MADE NOISE. THE UNIT WAS REPAIRED BY THE MANUFACTURER'S CHIEF ENGINEER WITH THE DISTRIBUTOR'S ASSISTANCE AND A COMPLETE REVIEW OF ALL SAFETY SYSTEMS WAS COMPLETED. THE MANUFACTURER ALSO REVIEWED ALL SYSTEM NOTES OF ALL MAINTENANCE REPORTED BY THE DISTRIBUTOR RELATED TO THIS SPECIFIC UNIT. THE REVIEW FOUND THAT THE DISTRIBUTOR HAD WORKED ON THE SAFETY NUT SWITCH AND DRIVE NUT AREA PREVIOUSLY IN MAY 2018. IT IS POSSIBLE THAT THE SERVICE PERFORMED DURING THE PREVIOUS SERVICE CALL BY THE DISTRIBUTOR WAS THE CAUSE OF THE SAFETY NUT SWITCH BEING IN A LOOSE AND INEFFECTIVE STATE. RECORDS FROM CASE FILES SHOW THERE WAS WORK COMPLETED IN THE AREA AROUND THE SAFETY NUT SWITCH. THIS SCENARIO IS FURTHERED DUE TO THE CHIEF ENGINEER'S DISCOVERY THAT THE SAFETY NUT SWITCH ACTUATOR ARM WAS MECHANICALLY BENT IN SUCH A WAY THAT IT WOULD HAVE MADE OPERATING MORE DIFFICULT. THIS BENT FORM IS NOT THE CONDITION THE UNIT WAS IN WHEN INSTALLED AT THE FACTORY AND TESTED BEFORE SHIPPING. PRIOR TO SHIPPING, THE MAIN DRIVE NUT, BRACKET AND SAFETY NUT SWITCH, AND SAFETY NUT ARE ALL INSTALLED ON THE ACME SCREW AND REQUIRED TO PASS TESTING. THE DISTRIBUTOR WILL BE RECEIVING ADDITIONAL TRAINING FROM THE MANUFACTURER. ATTACHED ARE THE DRAFT NOTES FROM THE CHIEF ENGINEER SITE VISIT AND INVESTIGATION.

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR WHO SPOKE WITH THE END USER, THE USER WAS RIDING THE UNIT UP FROM THE LOWER LANDING LEVEL, THE UNIT MADE A LOUD NOISE AND THEN DROPPED 3 TO 4 FEET TO THE GROUND/LOWER LANDING LEVEL. THE USER SUFFERED NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021995 BRUNO INDEPENDENT LIVING AIDS, INC VERTICAL PLATFORM LIFT ING BRUNO INDEPENDENT LIVING AIDS, INC VPL-3210B

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR