BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 5566799 · Received April 11, 2016

    Report

    Report Number
    3007420694-2016-00073
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 16, 2016
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z.O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND 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. THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT (H1) NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2016, ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT THE RESIDENT WAS BEING TRANSFERRED FROM TOILET USING OPERA PASSIVE FLOOR LIFT AND TOILET SLING. IT WAS NOTICED THAT THE RESIDENT STRAIGHTENED AND FELL THROUGH THE HOLE OF THE SLING STRIKING HER HEAD ON THE FLOOR. THE RESIDENT DID NOT HAVE AN INJURY AND STAFF WERE CONDUCTING HEAD INJURY REVIEW. EXECUTIVE DIRECTOR FEELS THAT NEITHER THE SLING OR LIFT FAILED. ON 01 APR 2016, ADDITIONAL INFORMATION WAS RECEIVED REGARDING CIRCUMSTANCES OF THE EVENT AND THE RESIDENT. IT WAS REPORTED THAT "RESIDENT RAISED ARMS WHEN BEING TRANSFERRED, RESIDENT HAS HISTORY OF RAISING ARMS AND BEING NON COMPLIANT. RESIDENT HAS PASSED AWAY NOT AS A RESULT OF THE INCIDENT."

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED, IT APPEARS MOST LIKELY THAT THE RESIDENT FALL THROUGH THE HOLE IN THE BOTTOM OF TOILET SLING. IT WAS INDICATED THAT THE RESIDENT RAISED HER ARMS WHEN BEING TRANSFERRED, AND IT WAS NOTICED THAT THIS RESIDENT HAS HISTORY OF RAISING ARMS. ARJOHUNTLEIGH WAS INFORMED THAT THE PERSON INVOLVED PASSED AWAY BUT NOT AS A CONSEQUENCE OF THE EVENT DESCRIBED ABOVE BUT DUE TO NATURAL CAUSES. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR GENERAL FAULT DESCRIPTION (SLIP OUT OF SLING). THE TREND OBSERVED FOR THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE LOW. THE OPERA LIFT AND THE SLING DEVICE WERE INSPECTED AND NO MALFUNCTIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THEREFORE, THE SLING AND THE LIFT WHICH WORK TOGETHER AS A SYSTEM WERE FOUND TO HAVE BEEN TO SPECIFICATION WHEN THE EVENT TOOK A PLACE. IT CAN BE ESTABLISHED THAT THE SYSTEM WAS BEING USED FOR PATIENT CARE WHEN THE EVENT TOOK PLACE BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO AN USE ERROR. THE TOILET SLING INVOLVED IN THE EVENT IS FITTED IN A SIMILAR MANNER TO THE STANDARD FOUR POINT SLING, EXCEPT, THE SLING IS NOT TAKEN TO THE BASE OF THE PATIENT'S SPINE, BUT FITTED WITH THE TOP OF THE HEAD SUPPORT AREA OF THE SLING LEVEL WITH THE TOP OF THE PATIENTS HEAD AS A GUIDE TO POSITIONING. TO PROVIDE THE BEST POSSIBLE ACCESS WHEN TOILETING THE SLING HAS A WIDE COMMODE OPENING AND BECAUSE OF THIS IT IS ESSENTIAL THAT: THE CORRECT SIZE SLING IS CHOSEN, RELATIVE TO THE WEIGHT AND HEIGHT OF PATIENT AND BOTH OF THE PATIENT'S ARMS ARE POSITIONED OUTSIDE THE SLING, OVER THE PADDED AREAS BUT UNDER THE "HEAD SECTION" SUPPORT STRAPS' THIS WILL HELP PREVENT THE PATIENT FROM SLIDING THROUGH THE SLING. WITH A TOILET SLING THE WEIGHT OF THE PERSON IS SUPPORTED BY THE LEG FLAPS, BUT ALSO AND TO A LARGE EXTENT BY THE SUPPORTS THAT ARE LOCATED UNDER THE ARMPITS AND TOWARDS THE SHOULDERS AND BACK OF THE PERSON LIFTED. EVEN WITH ARMS RAISED THIS SUPPORT REMAINS PRESENT. BASED ON THE PREVIOUS INVESTIGATIONS THE MOST LIKELY WAY TO SLIP OUT OF A TOILET SLING IS TO HAVE THE ARMS INSIDE OF THE SLING. NORMALLY IN ALL SLINGS THE ARMS SHOULD BE ON THE INSIDE, BUT WITH THE TOILET SLING THEY SHOULD BE ON THE OUTSIDE AS VERY CLEARLY DESCRIBED IN THE SLING IFU. THEREFORE, IT APPEARS MOST LIKELY THAT WHEN A PERSON PUTS ARMS INSIDE OF A TOILET SLING, THEN AS A CONSEQUENCE CAN SLIP OUT OF THE SLING. FOLLOWING THE INFORMATION GATHERED THE RESIDENT RAISED ARMS WHEN WAS BEING TRANSFERRED. IT WAS INDICATED THAT THE RESIDENT HAS HISTORY OF RAISING ARMS. THIS CAN BE AN INDICATION THAT NOT ENOUGH ATTENTION WAS PAID TO THE RESIDENT. BASED ON THE ABOVE EVALUATION WE CAN CONCLUDE THAT THE USE ERROR CANNOT BE RULED OUT, ESPECIALLY AS NO MALFUNCTIONS WERE FOUND ON THE LIFT AND THE SLING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THEREFORE, 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, AND THAT ONLY DUE TO THIS THE DEVICE CONTRIBUTED TO THE EVENT. THE CURRENT SLING INSTRUCTIONS FOR USE (IFU) AS SUPPLIED WITH EACH SLING INCLUDES IMPORTANT INFORMATION CONCERNING PROPER AND SAFE USE OF THE SLING DURING THE TRANSFER. - "WARNING: TO AVOID INJURY, ONLY USE THE TOILET SLING ON RESIDENTS WITH UPPER BODY STRENGTH. LACK OF UPPER BODY STRENGTH CAN CAUSE THE RESIDENT TO SLIDE OUT." - "WARNING: TO AVOID INJURY, ALWAYS ASSESS THE RESIDENT PRIOR TO USE." - "MAKE SURE THAT THE: (...) RESIDENT'S ARMS ARE OUTSIDE THE SLING." NOTE THAT THE CUSTOMER WAS VISITED AND INTERVIEWED BY A LOCAL ARJOHUNTLEIGH REPRESENTATIVE. THE TRAINING PROVIDED FOR THE CAREGIVERS WAS FOUND TO BE INSUFFICIENT AND IN THAT FACT ALL USERS MUST BE TRAINED AS PER IFU. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO THE CORRECT LIFTING PROCEDURE AND ALL STEPS CONCERNING PREPARING FOR TRANSFER. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222024 OPERA FSA FSA ARJO MED AB LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other