BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 2

    MDR report key: 17984669 · Received October 23, 2023

    Report

    Report Number
    9681684-2023-00074
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 23, 2023
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARJO FIELD SERVICE TECHNICIAN VISITED THE CUSTOMER FACILITY AFTER THE EVENT TO INSPECT THE CEILING INSTALLATION SYSTEM. THE EVALUATION REVEALED THAT THE CEILING LIFT DETACHED AS THE END STOPPER OF THE TURNTABLE DID NOT PREVENT THE CEILING LIFT FROM FALLING. THE INSTRUCTIONS FOR USE DEDICATED TO KWIKTRAK TURNTABLE (IFU 001.11720.EN REV.11) WARNS: "ALL TRACK ENDS MUST HAVE AN END STOPPER IN PLACE AND SECURED. THEY ARE PART OF SAFETY FEATURES. A MISSING END STOPPER MIGHT LEAD TO A PATIENT FALL." IT IS ALSO MENTIONED IN THE CARE AND MAINTENANCE SECTION: BEFORE EVERY USE "MAKE SURE END STOPPERS OF THE TURNTABLE ARE IN PLACE." THE KWIKTRAK TURNTABLE MUST BE INSPECTED BY A QUALIFIED ARJOHUNTLEIGH TECHNICIAN ON AN ANNUAL BASIS TO ENSURE PROPER FUNCTION OF ITS COMPONENTS, AS WELL AS THE SAFETY OF THE PATIENTS AND CAREGIVERS THAT USE THE PRODUCT. PLEASE CONTACT YOUR LOCAL AGENT TO MAKE ARRANGEMENTS." THIS CEILING INSTALLATION WAS ASSEMBLED IN 2018 BY ARJO. SINCE THEN, IT WAS NOT INSPECTED BY ARJO QUALIFIED TECHNICIAN. THERE IS NO SERVICE CONTRACT WITH ARJO IN PLACE. ARJO DEVICE FAILED TO MEET ITS SPECIFICATION SINCE THE CEILING LIFT DETACHED FROM THE TRACK. THE DEVICE WAS USED FOR A PATIENT TRANSFER WHEN THE FAILURE OCCURRED. THE COMPLAINT DECIDED TO BE REPORTABLE DUE TO MAXI SKY 2 DETACHMENT FROM THE CEILING INSTALLATION AND FALLING ON THE RESIDENT.

    Description of Event or Problem · 0

    ARJO WAS INFORMED ABOUT INCIDENT WITH MAXI SKY 2 CEILING LIFT AND KWIKTRAK CEILING INSTALLATION SYSTEM INVOLVEMENT. FOLLOWING CUSTOMER ALLEGATION, THE MAXI SKY 2 CEILING LIFT DETACHED FROM THE TURNTABLE AND FELL ON THE TRANSFERRED RESIDENT. THE RESIDENT SUSTAINED BUMP ON THE HEAD. THE TURNTABLE IS AN ACCESSORY USED FOR KWIKTRAK CEILING INSTALLATION. IT IS DESIGNED TO ALLOW THE CEILING LIFT TO PASS FROM ONE TRACK PATH TO ANOTHER. EACH SIDE OF THE TURNTABLE THAT IS NOT CONNECTED TO THE RAIL SHALL BE SECURED WITH THE END STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942460 MAXI SKY 2 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. MS010-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Other