BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUNO

    MDR report key: 10660077 · Received October 11, 2020

    Report

    Report Number
    2131358-2019-00002
    Event Type
    Malfunction
    Date Received
    October 11, 2020
    Date of Event
    February 17, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS INC.
    Product Code
    ING
    PMA / PMN Number
    K061514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SENT CHIEF ENGINEER FOR THE PRODUCT LINE AND SENIOR TECHNICAL TRAINER TO INSPECT THE UNIT IN THE FIELD. THEY FOUND THAT THE UNIT HAD BEEN MODIFIED SUCH THAT THE DOOR CLOSED SWITCH LEVER WAS BENT, PROTRUDING OUT OF THE GATE FRAME. ADDITIONALLY, THE GATE LATCH PLATE WAS COCKED ON AN UPWARD ANGLE AND WAS FOUND TO BE APPROXIMATELY THREE DEGREE'S OUT OF LEVEL. THE MISALIGNMENT OF THE GATE LATCH PLATE ALLOWED THE LATCH ROD TO TRAVEL JUST ENOUGH TO ENGAGE THE DOOR LOCK SWITCH, WHICH ALLOWED THE DOOR TO BE OPEN WHEN THE PLATFORM WAS NOT AT THE UPPER LANDING GATE. ONLY BECAUSE THESE TWO ISSUES OCCURRED SIMULTANEOUSLY, IN ADDITION TO THE USER FAILING TO LOOK TO SEE WHERE THE PLATFORM WAS LOCATED DID ANY INCIDENT OCCUR. THE GATE LATCH PLATE WAS FIXED BACK TO THE LEVEL FACTORY SETTING AND THE DOOR CLOSED SWITCH LEVER WAS BENT BACK TO THE FACTORY SETTING. THESE FIXES CAUSING THE GATE TO CLOSE COMPLETELY AFTER EVERY USE, AS DESIGNED, AND LOCK WHEN THE PLATFORM WAS NOT LOCATED AT THE UPPER LEVEL GATE. THE DEALER'S TECHNICIANS WERE RETRAINED ON PROPER INSTALLATION METHODOLOGY ESPECIALLY LEVELING THE PLATFORM GATE TO INSTALLATION MANUAL SPECIFICATIONS

    Description of Event or Problem · 1

    PERSON OPENED GATE AT UPPER LEVEL OF THE UNIT AND ATTEMPTED TO ENTER THE PLATFORM, HOWEVER THE PLATFORM WAS AWAY FROM THE UPPER LEVEL LANDING (BETWEEN UPPER AND LOWER LEVEL) AND PERSON WAS INJURED FALLING TO PLATFORM. PERSON WAS NOT USING PRODUCT IN ACCORDANCE WITH MANUFACTURER GUIDELINES AND INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124927 BRUNO VERTICAL PLATFORM LIFT ING BRUNO INDEPENDENT LIVING AIDS INC. VPL-3310B

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization