BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 6193407 · Received December 21, 2016

    Report

    Report Number
    9681684-2016-00067
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 16, 2016
    Report Date
    March 18, 2017
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684) ON BEHALF OF THE IMPORTER (B)(4) (REGISTRATION #(B(4)). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION FROM INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT DURING TRANSFER OF RESIDENT WITH MAXI MOVE LIFT AND SLING, RESIDENT SLIPPED OUT OF SLING. AS A CONSEQUENCES RESIDENT SUSTAINED CLOSED FRACTURE OF SEVEN RIBS AND CORACOID FRACTURE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (SLID OUT OF SLING). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE RELATIVELY LOW AND STABLE. IT HAS BEEN ESTABLISHED THAT THE LIFT DEVICE (MAXI MOVE) AND THE SLING WERE BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT. NO MALFUNCTIONS REGARDING THE LIFT WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE LIFT WAS FOUND TO HAVE BEEN IN ACCORDANCE TO THE PRODUCT SPECIFICATION WHEN THE EVENT TOOK A PLACE. IT WAS INFORMED THAT FAIR GOOD ERGO MED (NON ARJOHUNTLEIGH) SLING WAS USED WITH MAXIMOVE. SLING WAS TAKEN OUT OF SERVICE. FROM OUR PRODUCT KNOWLEDGE IN PART GAINED FROM REVIEW OF PREVIOUS COMPLAINTS AS WELL AS FROM SIMULATION PERFORMED THERE IS NO POSSIBILITY OF A PERSON TO SLIDE OUT OF THE SLING DURING ON LABEL USE. THERE ARE FEW ELEMENTS WHICH COULD CONTRIBUTE TO A PERSON SLIDING OUT FROM THE SLING, AS FOLLOWING: A SLING BEING USED THAT IS OF A VERY INAPPROPRIATE SIZE (SEVERAL SIZES OFF). AN OBVIOUS WRONG APPLICATION OF THE SLING (E.G.: SLING USED UPSIDE DOWN, WRONG TYPE OF THE SLING USED, WRONG POSITION OF THE RESIDENT/PATIENT ARMS). A SLING CLIP DETACHING OR NOT BEING ATTACHED TO THE LIFT DEVICE BEFORE STARTING THE TRANSFER. A SLING BEING USED WITH NO PLASTIC SUPPORT STAYS/STIFFENERS INSIDE THE HEAD SECTION OF THE SLING, AND THE PERSON BEING POSITIONED INTO THE MOST HORIZONTAL POSITION. THIS SITUATION WOULD LIKELY BE AGGRAVATED AND A SLIDE OUT FROM THE TOP OF THE SLING FACILITATED, IF THE PERSON WAS REPOSITIONED TO THE HORIZONTAL MORE QUICKLY THAN NORMAL, OR AT AN INCLINE BIGGER THAN NORMAL. IT SHOULD BE EMPHASIZED THAT BASED ON THE GATHERED INFORMATION NON ARJOHUNLTEIGH SLING WAS USED WITH MAXI MOVE LIFT DURING TRANSFER. ACCORDING TO THE INSTRUCTION FOR USE FOR MAXI MOVE LIFT (001.25060): "MAXI MOVE ALWAYS MUST BE HANDLED BY A TRAINED CAREGIVER AND IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS MANUAL" "WARNING: ONLY USE ARJOHUNTLEIGH SUPPLIED SLINGS AND STRETCHERS THAT ARE DESIGNED TO BE USE WITH MAXI MOVE." FROM THIS EVALUATION IT WOULD APPEAR MOST LIKELY THAT THE EVENT WAS CAUSED BY THE USER NOT FOLLOWING THE IFU (UNAPPROVED USAGE OF THE ARJOHUNTLEIGH PRODUCT), DUE TO LACK OF AWARENESS OF THE IFU CONTENTS. OUR INVESTIGATION SHOWS THAT IF THE IFU SAFETY WARNINGS ARE FOLLOWED, IT WILL NOT POSE PATIENT OR CAREGIVER AT RISK. ARJOHUNTLEIGH PERFORMED TRAINING FOR THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT CHOSE AND CHECK SLING BEFORE TRANSFER AS WELL AS LIFTING PROCEDURE. IT WAS COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Description of Event or Problem · 1

    ON (B)(6) 2016 (B)(4) RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT RESIDENT FELL TO THE FLOOR FROM SLING WHICH WAS USED WITH MAXI MOVE LIFT. RESIDENT SUSTAINED FRACTURE OF SEVEN RIBS. IT WAS DETERMINED THAT RESIDENT SHOULD BE SENT TO HOSPITAL FOR FURTHER EVALUATION. THE FOLLOWING WAS REPORTED: "RESIDENT LEFT ON FLOOR, COVERED WITH A BLANKET AND STAFF MEMBER IN ATTENDANCE UNTIL AMBULANCE CAME AND TRANSPORTED RESIDENT TO HOSPITAL WHERE SHE WAS SUBSEQUENTLY ADMITTED WITH DIAGNOSIS OF CLOSED FRACTURE OF SEVEN RIBS (PRIMARY DIAGNOSIS); CLOSED CORACOID PROCESS FRACTURE; FALL; FRACTURE OF MULTIPLE RIBS OF RIGHT SIDE, INITIAL ENCOUNTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845253 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. KMCLXN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization