BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 6595245 · Received May 26, 2017

    Report

    Report Number
    3007420694-2017-00127
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    July 3, 2016
    Report Date
    May 26, 2017
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG, INC. / 9681684). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ON 2016-JULY-12 ARJOHUNTLEIGH HAS BECOME AWARE OF A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT WHEN TRANSFERRING A RESIDENT FROM BED TO WHEELCHAIR UTILIZING MAXI MOVE PASSIVE FLOOR LIFT, THE RESIDENT SLIPPED OUT OF SLING AND FELL. THE CAREGIVER, SUPPORTING HIM TO PREVENT FROM FALLING, FELL OVER ONTO THE FLOOR AS WELL. FORTUNATELY NO INJURY WAS SUSTAINED - NEITHER BY RESIDENT, NOR BY CAREGIVER. THE RESIDENT PASSED FOLLOWING MEDICAL EXAMINATIONS AFTER THIS EVENT: NEUROSURGERY, OTOLARYNGOLOGIST, OPHTHALMOLOGY, RACHIS COMPLETE, BRAIN, CHEST AND PELVIS COMPUTERIZED AXIAL TOMOGRAPHY WITH NEGATIVE RESULTS. THE LIFT AND THE SLING INVOLVED WITH THIS INCIDENT WERE INSPECTED BY ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENT. NO MALFUNCTION OF THE DEVICES WAS DETECTED. BOTH WERE IN GENERAL GOOD CONDITION. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (SLID OUT OF SLING). IF COMPARED TO THE NUMBER OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USAGE, THE OCCURRENCE RATE FOR REPORTABLE COMPLAINTS CLAIMING THIS FAILURE MODE IS CONSIDERED TO BE LOW. BASED ON PRODUCT KNOWLEDGE, REVIEW OF PREVIOUS COMPLAINTS AS WELL AS FROM PERFORMED SIMULATIONS THERE IS NO POSSIBILITY OF A PERSON TO SLIDE OUT OF THE SLING DURING ON-LABEL USE OF THE DEVICE. THERE ARE FEW FACTORS THAT COULD CONTRIBUTE TO A PERSON SLIDING OUT FROM THE SLING, AS FOLLOWING: 1. A SLING BEING USED THAT IS OF A VERY INAPPROPRIATE SIZE (SEVERAL SIZES OFF). 2. 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). 3. A SLING CLIP DETACHING OR NOT BEING ATTACHED TO THE LIFT DEVICE BEFORE STARTING THE TRANSFER. 4. 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. HOWEVER, DUE TO LIMITED INFORMATION RECEIVED, NONE OF THE ABOVE SCENARIOS CAN BE POINTED OUT WITH A CERTAINTY AS AN EXACT FACTOR CONTRIBUTING TO THIS PARTICULAR EVENT. PLEASE NOTE THAT THE SLING INSTRUCTION FOR USE CONTAINS THE FOLLOWING WARNINGS IN ORDER TO DIMINISH POSSIBILITY OF PATIENT SLIPPING OUT OF THE SLING OR ANY OTHER MISUSE: "WARNING: TO AVOID INJURY ALWAYS READ THIS INSTRUCTION FOR USE AND ACCOMPANIED DOCUMENTS BEFORE USING THE PRODUCT. MANDATORY TO READ THE INSTRUCTION FOR USE." "WARNING TO AVOID THE RESIDENT FROM FALLING, MAKE SURE TO SELECT THE CORRECT SLING SIZE ACCORDING TO THE IFU". "WARNING TO AVOID INJURY MAKE SURE THAT THE RESIDENT IS NOT LEFT UNATTENDED AT ANY TIME." "WARNING TO AVOID INJURY, MAKE SURE THE RESIDENT'S ARMS ARE PLACED INSIDE OF THE SLING." FROM THIS EVALUATION, IT WOULD APPEAR MOST LIKELY THAT THE EVENT WAS CAUSED BY THE USER NOT FOLLOWING THE IFU, DUE TO LACK OF AWARENESS OF THE IFU CONTENTS. WE FIND THE CAUSE TO BE RELATED WITH LACK OR INSUFFICIENT TRAINING. ARJOHUNTLEIGH SUGGESTS REMINDING THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT LIFTING PROCEDURE. THIS WAS COMMUNICATED TO THE CUSTOMER. LOOKING AT THE INCIDENT SCENARIO, IT IS FOUND THE DEVICE WAS BEING USED FOR PATIENT HANDLING WHEN THE EVENT OCCURRED AND IT WAS ALSO DIRECTLY INVOLVED WITH THE REPORTABLE INCIDENT AS THE PATIENT SLIPPED OUT OF SLING DURING TRANSFER. THE DEVICE WAS UP TO ITS SPECIFICATION AT THE TIME OF THE INCIDENT AS NO MALFUNCTION WAS DETECTED DURING THE INSPECTION AFTER THE EVENT OCCURRED. - ATTACHMENT: [COVER LETTER.PDF]

    Description of Event or Problem · 0

    ON 2016-JULY-12 ARJOHUNTLEIGH HAS BECOME AWARE OF A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT WHEN TRANSFERRING A RESIDENT FROM BED TO WHEELCHAIR UTILIZING MAXI MOVE PASSIVE FLOOR LIFT, THE RESIDENT SLIPPED OUT OF SLING AND FELL. THE CAREGIVER, SUPPORTING HIM TO PREVENT FROM FALLING, FELL OVER ONTO THE FLOOR AS WELL. FORTUNATELY, NO INJURY WAS SUSTAINED - NEITHER BY RESIDENT, NOR BY CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374571 MAXI MOVE NON-AC-POWERED PATIENT LIFT FSA ARJO MED. AB LTD. KRA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other