BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERA

    MDR report key: 5847924 · Received August 4, 2016

    Report

    Report Number
    3007420694-2016-00163
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    July 7, 2016
    Report Date
    July 7, 2016
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    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. B 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. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED IT WAS INDICATED THAT DURING THE PATIENT'S TRANSFER TO CHAIR BOTH LEG CLIPS OF THE SLING DETACHED FROM THE LUGS OF THE LIFT SPREADER BAR AND THE RESIDENT FELL ON THE FLOOR. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (CLIP DETACHMENT). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE LOW AND STABLE. THE OPERA LIFT WAS INSPECTED, NO MALFUNCTIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THE FACILITY HAD REMOVED THE SLING FROM USE DUE TO AGE HOWEVER A STAFF PERSON HAD FOUND THE SLING AND USED IT WHEN IT SHOULDN'T HAVE BEEN USED. AN ON SITE INSPECTION FOUND THE SLING INVOLVED TO BE FITTED WITH "GREY" CLIPS. PRODUCTION OF SLINGS WITH GREY CLIPS HAS STOPPED SOME TIME AGO (BETWEEN 2005 2006). FOLLOWING THE LIFT INSTRUCTION FOR USE (IFU) FOR THESE ITEMS THE SLING SHOULD BE DISCARDED AFTER TWO YEARS LIFETIME, OR BEFORE THAT, WHEN DAMAGED. THE SLING INVOLVED THEREFORE WAS SIGNIFICANTLY PAST ITS LIFETIME. THIS HAS NOT IMPACTED ON THE PERFORMANCE OF THE SLING WHEN USING ACCORDING TO THE IFU BUT THIS IS AN INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, AND ALSO INDICATES THAT THE IFU WAS NOT BEING FOLLOWED. ACCORDING TO THE ABOVE THE SLING AND THE LIFT WHICH WORK TOGETHER AS A SYSTEM WERE FOUND TO HAVE NOT BEEN TO SPECIFICATION WHEN THE EVENT TOOK A PLACE. IT CAN BE ESTABLISHED THAT THE SLING AND THE LIFT WERE BEING USED FOR PATIENT HANDLING BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO A USE ERROR. A SLING CLIP, ONCE CORRECTLY ATTACHED AND MONITORED TO STAY IN PLACE AS THE WEIGHT OF THE PERSON IN THE SLING IS GRADUALLY TAKEN UP, AS INDICATED TO BE REQUIRED IN THE LABELLING, IS LOCKED IN POSITION WITH THE WEIGHT OF THE PATIENT. IT IS NOT LIKELY TO COME OFF DURING ON LABEL USE WE OFFER THESE SCENARIO'S AS OUR SIMULATIONS SHOW THAT DURING USE ACCORDING TO INSTRUCTIONS IT IS IMPOSSIBLE FOR BOTH THE LEG CLIPS TO COME OFF WHILE LOADED DURING TRANSFER. NOT EVEN WHEN THE SLING OCCUPANT IS IN A VERY PARTICULAR POSITION WHERE THEIR KNEE CAN PUSH UP THE CLIP, AND THERE IS AN INTENTION AND STRENGTH PRESENT TO DO SO, CAN THIS LEAD TO TWO CLIPS COMING LOOSE: BASED ON PRODUCT KNOWLEDGE AND PREVIOUSLY MADE SIMULATIONS THIS THEN LEAVES OPEN A POSSIBLE SEQUENCES OF EVENTS: 1) FOLLOWING ALL DETAILS REPORTED THE PATIENT WAS LIFTED FROM THE BED, THEREFORE FROM THE HORIZONTAL POSITION. FROM SIMULATIONS, WE KNOW THAT A PERSON CAN BE LIFTED FROM A HORIZONTAL POSITION WITH ONE OF THE LEG CLIPS NOT IN PLACE. HOWEVER, TYPICALLY WHEN THE PATIENT IS AT THE END OF THAT TRANSFER, PUT INTO A MORE UPRIGHT, SEATED POSITION BEFORE LOWERING TO A WHEELCHAIR, THE WEIGHT SHIFTS TOWARDS THE MISSING CLIP STRAP AND THE PERSON FALLS OUT. FOLLOWING THE ABOVE SCENARIO, IT WOULD APPEAR POSSIBLE THAT ONE OF THE CLIPS WAS NOT IN PLACE AT THE START OF THE LIFTING PROCEDURE (IT COULD HAVE BECOME WIGGLED OFF BEFORE BEING LIFTED FROM BED) AND WHEN THE WEIGHT WOULD SHIFT AS THE PATIENT WAS PUT INTO A MORE UPRIGHT, VERTICAL POSITION THE PERSON WOULD SLIDE OUT, WHICH MIGHT HAVE LOOKED LIKE TWO CLIPS HAVING COME UNDONE WHILE THERE WAS ONLY ONE ALREADY UNDONE. 2) THERE ARE ADDITIONAL SCENARIOS THAT ALSO INVOLVE USE THAT IS NOT FOLLOWING THE IFU: WHEN A TRANSFER OCCURS FROM A BED, THIS MEANS AT SOME POINT THERE MUST BE A REPOSITIONING FROM HORIZONTAL TO SEATED POSITION. THIS THEN MEANS THAT THE RESIDENT MUST BE TURNED IN THE CORRECT DIRECTION. AS A RESULT THE CAREGIVER MUST MANIPULATE THE SPREADER BAR THAT HOLDS THE SLING AND IS ABLE TO TURN FOR THIS PURPOSE. THE INTENDED AND LABELLED USE IS THAT THIS OCCURS BY OPERATING AND MANIPULATING THE SPREADER BAR ITSELF, AND NOT THE SLING NOR THE PERSON IN THE SLING. IF THIS LABELLING IS FOLLOWED THERE CAN BE NO ISSUE. HOWEVER, IT IS POSSIBLE FOR THE CAREGIVER TO NOT HAVE FOLLOWED THE LABELLING AND HAVE USED THE PERSON IN THE SLING TO MANIPULATE THE SPREADER BAR. IN THIS CASE THE CLIP COULD BE INADVERTENTLY PULLED OFF BY THE CAREGIVER WHILE USING THE SLING OR THE PERSON IN THE SLING FOR REPOSITIONING. FOR THIS SCENARIO TO FIT THE DESCRIPTION OF TWO CLIPS HAVING COMING LOOSE, THE CAREGIVER MUST HAVE PULLED BOTH STRAPS AT THE TOP OF THE LEG CLIPS AT THE SAME TIME, CAUSING THE DETACHMENT. THE OPERA LIFT IFU INCLUDES INFORMATION ABOUT SAFE AND CORRECT USE OF THE PRODUCT: "WARNING: IMPORTANT: ALWAYS CHECK THAT ALL THE SLING ATTACHMENT CLIPS ARE FULLY IN POSITION BEFORE AND DURING THE LIFTING CYCLE, AND IN TENSION AS THE PATIENT'S WEIGHT IS GRADUALLY TAKEN UP". 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. 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 CORRECT LIFTING PROCEDURE. THIS IS TO BE COMMUNICATED TO THE CUSTOMER.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING TRANSFER FROM BED TO CHAIR USING OPERA LIFT AND SLING CLIP, WHILE RESIDENT REPOSITIONING IN CHAIR, BOTH LEG CLIPS OF THE SLING DISENGAGED FROM THE LUGS OF THE LIFT SPREADER BAR AND THE RESIDENT FELL ON THE FLOOR. AS A CONSEQUENCE THE RESIDENT SUSTAINED A HEAD CUT WHICH REQUIRED SUTURES. IT WAS REPORTED THAT THE FACILITY HAD REMOVED THE SLING FROM USE HOWEVER A STAFF PERSON HAD FOUND THE SLING AND USED IT WHEN IT SHOULDN'T HAVE BEEN USED. NEW SLINGS HAD BEEN PURCHASED TO REPLACE AGED SLINGS WITH THE GREY CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499795 OPERA OPERA FSA ARJO MED AB LTD KPB30*

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention