BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP SLING ¿ PADDED LEGS

    MDR report key: 23847330 · Received December 19, 2025

    Report

    Report Number
    3012292104-2025-00005
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 29, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ARJO DOMINICAN REPUBLIC
    Product Code
    FSA
    UDI-DI
    05055982796606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. THE INVESTIGATION IS ONGOING. RESULTS OF THE ANALYSIS WILL BE PROVIDED TO THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    BASED ON THE COLLECTED INFORMATION, THE RESIDENT FELL FROM THE ARJO SLING DUE TO THE LEG CLIP DETACHMENT. THE ARJO SLING WAS USED WITH A NON-ARJO LIFT, IDENTIFIED AS THE POWERMOVE MINI TTM 1060577, MANUFACTURED BY JOYINCARE (NON-ARJO). UNDER NO CIRCUMSTANCES SHOULD ARJO¿S CLIP ATTACHMENT SYSTEM BE USED WITH THIRD-PARTY PATIENT TRANSFER EQUIPMENT, AS ARJO¿S SPREADER BAR LUGS HAVE BEEN EXCLUSIVELY DESIGNED TO WORK WITH ARJO¿S CLIP SLINGS. ACCORDING TO ARJO CLIP SLINGS INSTRUCTIONS FOR USE (IFU 04.SC.00-9EN FROM DEC/2023): ¿THE PASSIVE CLIP SLING SHOULD BE USED TOGETHER WITH ARJO LIFT DEVICES IN ACCORDANCE WITH THE ALLOWED COMBINATIONS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU).¿ AS PER IFU, THE INVOLVED SLING MODEL MAA4000M CAN BE USED ONLY WITH MAXI TWIN COMPACT, MAXI LITE, MAXI 500, MAXI TWIN, MAXI MOVE, OR MAXI SKY. THE IFU ALSO STATES: ¿WARNING: TO AVOID INJURY, ALWAYS FOLLOW THE ALLOWED COMBINATIONS LISTED IN THIS IFU. NO OTHER COMBINATIONS ARE ALLOWED.¿ ¿THE PASSIVE CLIP SLINGS ARE INTENDED TO BE USED WITH ARJO LIFTERS EQUIPPED WITH CLIP SPREADER BARS ONLY.¿ THE EVENT WAS CAUSED BY THE USE OF AN ARJO SLING WITH A NON-ARJO LIFT. NO MANUFACTURING ISSUES WERE IDENTIFIED, AND THE SLING WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE DEVICE WAS BEING USED WITH THE RESIDENT AT THE TIME THE REPORTED ISSUE OCCURRED. THE COMPLAINT WAS DEEMED REPORTABLE DUE TO THE ALLEGATION THAT A RESIDENT FELL. THE FALL WAS CAUSED BY THE DETACHMENT OF THE LEFT LEG CLIP FROM THE NON-ARJO LIFT, AND THEREFORE THE ARJO DEVICE WAS INVOLVED IN THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A RESIDENT FELL FROM AN ARJO SLING THAT WAS BEING USED WITH A NON-ARJO LIFT (JOYINCARE). DURING A VISIT TO THE CUSTOMER¿S FACILITY, IT WAS CLARIFIED THAT THE FALL WAS CAUSED BY THE DETACHMENT OF THE LEFT LEG CLIP FROM THE LIFT. IMMEDIATELY BEFORE IT DETACHED, AN UNRECOGNIZABLE SOUND (A SNAP) WAS HEARD BY THE CAREGIVER.THE CARE RECIPIENT WAS BEING GUIDED TO THE FLOOR AND SUSTAINED A SCRAPE ON THE HEAD; NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE CAREGIVER REPORTED PSYCHOLOGICAL DISTRESS, INCLUDING SLEEP DISTURBANCE, AND PLANS TO SEE A TRAUMA THERAPIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258265 CLIP SLING ¿ PADDED LEGS LIFT, PATIENT, NON-AC-POWERED FSA ARJO DOMINICAN REPUBLIC MAA4000M-XL 05055982796606

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Other