BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI SKY 2

    MDR report key: 22070611 · Received May 22, 2025

    Report

    Report Number
    9681684-2025-00043
    Event Type
    Death
    Date Received
    May 22, 2025
    Date of Event
    April 23, 2025
    Report Date
    July 7, 2025
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    UDI-DI
    05055982770934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS PENDING COMPLETION. ONCE IT IS COMPLETED, THE SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COLLECTING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. UDI: (B)(4). THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT FELL FROM THE SLING USED WITH THE MAXI SKY 2 CEILING LIFT. DURING THE TRANSFER, THE RIGHT SIDE OF THE SPREADER BAR TOUCHED THE BED POLE. THE SPREADER BAR MOVED INTO A VERTICAL POSITION, WHICH ALLEGEDLY CAUSED TWO ATTACHMENT POINTS OF THE SLING TO SLIP OUT OF THE SPREADER BAR HOOK, RESULTING IN A PATIENT FALLING. THE PATIENT SUSTAINED A SUBDURAL HEMATOMA AND A FRACTURE OF THE LEFT SHOULDER. ALMOST 3 WEEKS LATER ARJO WAS INFORMED THAT THE PATIENT HAD PASSED AWAY. THE LIFT AND THE SLING REMAINED IN USE AFTER THE INCIDENT. THE DEVICE WAS INSPECTED AND NO MALFUNCTION WAS DETECTED. THE DEVICE OPERATED CORRECTLY. THE 2-HOOK SPREADER BAR IS A COMPONENT USED TO ATTACH A LOOP SLING FOR A RESIDENT TRANSFER. THE SPREADER BAR CONSISTS OF A SINGLE ROD WITH ROUNDED HOOKS ON BOTH ENDS, WITH SECURED LOCKING LATCHES, DESIGNED TO HOLD THE SLING LOOPS IN PLACE. THE PHOTOGRAPHIC EVIDENCES PROVIDED BY THE CUSTOMER WERE REVIEWED AND FOUND THAT IT IS UNLIKELY THAT THE LOOPS DETACH FROM THE HOOK AS THE PATIENT WEIGHT AND GRAVITY WOULD KEEP THE LOOP IN PLACE, EVEN THOUGH THE LOCKING MECHANISM WAS IN AN OPEN POSITION. ADDITIONAL SIMULATION PERFORMED USING RANDOM SAMPLE, AT THE MANUFACTURING SITE, SHOWED THAT THE DETACHMENT IS ALSO UNLIKELY FOR THE SECOND HOOK, NOT ONLY BECAUSE OF GRAVITY, BUT ALSO DUE TO A BUILT-IN LOCKING FEATURE. THE LOCKING MECHANISM WAS STILL IN CLOSED POSITION. THEREFORE, IT HAS BEEN SUGGESTED THAT THE PATIENT COULD SLIDE OUT OF THE SLING, AS THE VERTICAL POSITION OF THE SPREADER BAR IS NOT STABLE AND ANY UNEXPECTED PATIENT MOVEMENTS FURTHER INCREASES INSTABILITY, RAISING THE LIKELIHOOD OF THE PATIENT SLIDING OUT OF THE SLING. THE HYPOTHESIS IS THAT THE PATIENT SLID OUT OF THE SLING FIRST CAUSING THE LOOP TO LEAVE THE SPREADER BAR HOOK. MAXI SKY 2 CEILING LIFT INSTRUCTION FOR USE (IFU) GUIDES THROUGH PROPER TRANSFER USING THE LIFT. THE INSTRUCTION STATES TO ¿BEFORE TRANSFERRING A PATIENT, MAKE SURE THERE ARE NO OBSTACLES IN THE TRANSFER PATH. INJURIES COULD OCCUR.¿ BASED ON THE AVAILABLE INFORMATION AND THE ANALYSIS PROVIDED BY THE MANUFACTURER, IT IS POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE SPREADER BAR MOVING TO A VERTICAL POSITION, AS RELATED TO THE OBSTACLE. ACCORDING TO IFU THE CAREGIVER SHALL ENSURE THERE IS NO OBSTACLE ON THE LIFT PATH. FROM THAT PERSPECTIVE THIS SITUATION IS RELATED TO A HANDLING ERROR. IT IS UNLIKELY THAT THE LOOPS DETACH FROM THE HOOK, EVEN IF THE SPREADER BAR IS IN VERTICAL POSITION. THIS INCIDENT IS A SINGULAR OCCURRENCE. ARJO DEVICE WAS USED FOR A PATIENT TREATMENT WHEN THE EVENT OCCURRED AND FROM THAT PERSPECTIVE IT PLAYED A ROLE IN THE EVENT. THE DEVICE WAS PERFORMING AS INTENDED. NO MALFUNCTION WAS FOUND DURING THE DEVICE EVALUATION. THIS ADVERSE EVENT WAS REPORTED DUE TO CUSTOMER ALLEGATION OF LOOP DETACHMENT AND PATIENT FALLING FROM THE SLING.

    Description of Event or Problem · 0

    ARJO BECAME AWARE OF THE PATIENT FALL FROM THE SLING USED WITH MAXI SKY 2 CEILING LIFT. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE SPREADER BAR GOT HOOKED ON THE LIFTING POLE OF THE BED, WHICH CAUSED IT TO TILT AND LED TO THE 2 POINTS OF THE SLING SLIPPED OUT AND THE PATIENT FELL ON THE FLOOR. AS A RESULT, A PATIENT SUSTAINED THE SUBDURAL HEMATOMA AND FRACTURED SHOULDER. ON 13 MAY, WE HAVE LEARNT THAT THIS SUBSEQUENTLY RESULTED IN THE PATIENT'S DEATH. CEILING LIFT AND SLING EVALUATION REVEALED NO FAULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971951 MAXI SKY 2 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. MS000-00-00 05055982770934

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death