BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINOVA

    MDR report key: 19838253 · Received July 26, 2024

    Report

    Report Number
    3009538853-2024-00001
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 26, 2024
    Manufacturer
    KINOVA
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    KINOVA'S INVESTIGATION OF THE EVENT, INCLUDING A PHYSICAL INSPECTION OF THE JACO ARM AS INSTALLED ON THE USER'S WHEELCHAIR, DETERMINED THAT, IN ONE SPECIFIC POSITION, THE WHEELCHAIR WAS LIVE WITH 24 VOLTS DC CURRENT. THE WHEELCHAIR SPECIALIST INVESTIGATING THE EVENT CONFIRMED THAT THE CURRENT CAME FROM A WHEELCHAIR POWER MODULE THAT WAS DAMAGED, ALLOWING CONTACT BETWEEN POWER PINS AND THE WHEELCHAIR FRAME. THE JACO ARM WAS DAMAGED BY THE CONTACT IT MADE WITH THE ARMREST OF THE WHEELCHAIR. THE CURRENT FROM THE WHEELCHAIR FLOWING THROUGH THE DAMAGED PART OF THE JACO IS THE CAUSE OF THE FIRE. UPON FURTHER INVESTIGATION, KINOVA DETERMINED THAT THE COMBINATION OF A WHEELCHAIR EXHIBITING ELECTRICAL LEAKAGE WITH A DAMAGED JACO ARM (ESPECIALLY DAMAGED COATING OR MISSING PLASTIC RING PART ) COULD RESULT IN A FIRE IF THE JACO ARM IS IN CONTACT WITH THE FAULTY WHEELCHAIR. THE ELECTRICAL CURRENT MAY FLOW THROUGH THE ROBOTIC ARM, RESULTING IN SMOKE, MELTING OF THE ARM, AND/OR FIRE.

    Description of Event or Problem · 0

    A USER REPORTED THAT: "... SMOKE STARTED POURING OUT OF THE [JACO] ARM AND THE CASING MELTED". THE JACO ARM WAS NOT IN USE AT THE TIME OF THE EVENT AND WAS STOWED UNDER THE WHEELCHAIR'S ARMREST. THE USER'S CAREGIVER DISCONNECTED THE ARM AND THERE WAS NO INJURY TO THE USER OR CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914107 KINOVA JACO IQZ KINOVA PJ0090-006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female PERMOBIL MID WHEEL DRIVE M5 2022