BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATALANTE X

    MDR report key: 21785658 · Received April 7, 2025

    Report

    Report Number
    3015000676-2025-00001
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 7, 2025
    Manufacturer
    WANDERCRAFT
    Product Code
    PHL
    PMA / PMN Number
    K232077
    Removal / Correction Number
    3015000676-040325-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WANDERCRAFT HAS INITIATED A FIELD CORRECTION APPLICABLE TO ALL ATALANTE X DEVICES WHEN USED IN COMBINATION WITH MOBILE PATIENT LIFTS. THIS CORRECTIVE ACTION INCLUDES UPDATED INTRUCTIONS FOR USE AND ENHANCED TRAINING MATERIALS FOR DEVICE OPERATORS.

    Description of Event or Problem · 0

    THE INCIDENT OCCURRED IN FRANCE AT THE END OF A GAIT TRAINING SESSION USING THE ATALANTE X EXOSKELETON WITH A HEMIPLEGIC PATIENT WHO IS 1.90 METERS TALL (6 FEET 3 INCHES) AND WEIGHS 105 KG (231 POUNDS). THE SESSION WAS SUPERVISED BY A CERTIFIED THERAPIST RESPONSIBLE FOR OPERATING THE EXOSKELETON, AND AN ASSISTANT IN CHARGE OF THE MOBILE PATIENT LIFT SYSTEM TO WHICH THE EXOSKELETON WAS ATTACHED. AT THE CONCLUSION OF THE SESSION, THE EXOSKELETON AUTOMATICALLY RETURNED TO THE STANDSTILL (UPRIGHT STANDING) POSITION. THE THERAPIST MOMENTARILY STEPPED AWAY TO RETRIEVE A BENCH INTENDED FOR THE EXOSKELETON TO SIT ON. AT THE SAME TIME, THE ASSISTANT RELEASED THE MOBILE PATIENT LIFT TO ENGAGE IN CONVERSATION WITH THE PATIENT. DURING THIS TRANSIENT LOSS OF DIRECT OVERSIGHT, THE EXOSKELETON LOST LATERAL BALANCE AND PULLED THE PATIENT LIFT ALONG WITH IT. THE TRAJECTORY OF THE MOBILE PATIENT LIFT LED IT TO STRIKE NEARBY CHAIRS, FURTHER COMPROMISING ITS STABILITY. BOTH THE THERAPIST AND ASSISTANT REACTED IMMEDIATELY AND WERE ABLE TO CATCH THE EXOSKELETON AND THE PATIENT LIFT BEFORE THEY HIT THE GROUND, PREVENTING INJURY TO THE PATIENT AND TO THE OTHER PERSONS AROUND. CONSEQUENCES: · NO INJURY TO THE PATIENT. · THE THERAPIST AND THE ASSISTANT PRESENTED WITH MINOR INJURIES, INCLUDING BRUISING TO THE THIGHS AND SHINS, AND MILD FRICTION BURNS FROM CLOTHING DURING THE INTERVENTION. · WHILE NO SERIOUS OUTCOMES OCCURRED, THIS SITUATION COULD HAVE LED IN MORE SEVERE INJURIES. IDENTIFIED CAUSES: · PATIENT WEIGHT EXCEEDED THE DEVICE'S SPECIFIED LIMIT (105 KG VS. 100 KG), WHICH MAY HAVE COMPROMISED STABILITY. · THE FLOOR SURFACE WAS COVERED WITH NON-SLIP MATERIAL, CAUSING EXCESSIVE FRICTION UNDER THE FEET OF THE EXOSKELETON, POTENTIALLY PREVENTING A STABLE RETURN TO THE STANDSTILL POSITION. · LACK OF SIMULTANEOUS SECURING OF BOTH THE EXOSKELETON AND THE MOBILE PATIENT LIFT BY THE CLINICAL STAFF. · PRESENCE OF OBSTACLES (CHAIRS) IN THE FALL TRAJECTORY, WORSENING THE IMBALANCE. TO CONCLUDE, NO DEVICE TECHNICAL MALFUNCTION WAS IDENTIFIED. THE INCIDENT APPEARS TO HAVE RESULTED FROM A COMBINATION OF HUMAN FACTORS AND ENVIRONMENTAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956890 ATALANTE X POWERED LOWER LIMB EXOSKELETON PHL WANDERCRAFT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other