BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 5778100 · Received July 8, 2016

    Report

    Report Number
    3007420694-2016-00122
    Event Type
    Injury
    Date Received
    July 8, 2016
    Report Date
    June 10, 2016
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 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. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. IT APPEARS FROM THE EVENT DESCRIPTION BY THE USER, THAT AT THE START OF A RESIDENT TRANSFER FROM BED TO WHEELCHAIR ONE OF THE SLING CLIPS CAME LOOSE FROM THE SPREADER BAR OF THE TEMPO LIFT AND THE RESIDENT SLID OUT OF THE SLING FALLING ON THE FLOOR. THIS IS DESCRIBED TO HAVE TAKEN PLACE IMMEDIATELY AFTER THE SLING STRAPS WERE SECURED TO THE LIFT BY ATTACHING THE CLIPS, WHEN THE STAFF PROCEEDED TO MOVE FROM THE BED TOWARD THE CHAIR, AT WHICH POINT IT IS ALLEGED A CLIP AND STRAP CAME OFF THE SPREADER BAR AND THE PATIENT FELL TO THE GROUND. IT IS NOT CLEAR WHICH CLIP AND STRAP ALLEGEDLY BECAME DETACHED FROM THE SYSTEM CONNECTION. 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 TEMPO LIFT WAS INSPECTED, NO MALFUNCTIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT 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 IS AN INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, AND ALSO INDICATES THAT THE IFU WAS NOT BEING FOLLOWED. ADDITIONALLY, IT WAS FOUND WHEN THE SLING WAS QUARANTINED THAT ONE OF THE SLING CLIP INSERTS HAD POPPED OUT. 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. BASED ON PRODUCT KNOWLEDGE AND PREVIOUSLY MADE SIMULATIONS WE HAVE ESTABLISHED THAT DURING USE ACCORDING TO THE LIFT DEVICE AND SLING INSTRUCTIONS FOR USE, IT IS NOT LIKELY A CLIP CAN COME OFF DURING TRANSFER. THIS THEN LEAVES OPEN THE FOLLOWING POSSIBLE SEQUENCE OF EVENTS: 1) WHEN A LEG CLIP IS NOT ATTACHED (FORGOTTEN) OR IT IS ATTACHED BUT IS NOT MONITORED TO STAY IN PLACE WHILE THE STRAPS COME UNDER TENSION AS THE WEIGHT OF THE PERSON IN THE SLING IS LOADED AND THEREFORE CAN BE WIGGLED OFF WHEN THE TRANSFER IS STARTING - IT IS POSSIBLE TO LIFT A PERSON FROM THE BED, AND TRANSFER THEM FROM THE BED. IN SUCH SCENARIO IT IS POSSIBLE THAT THE PERSON WILL NOT SLIDE OUT OF THE SLING UNTIL THE PERSON IS REPOSITIONED TOWARDS A SEATED POSITION, AND THEREFORE TOWARDS THE MISSING LEG CLIP, WHICH THEN CAN CAUSE A DROP. 2) ALTERNATIVELY, AND MORE IN LINE WITH THE EVENT DESCRIPTION, WHEN A SHOULDER CLIP IS NOT ATTACHED (FORGOTTEN) - OR IT IS NOT MONITORED TO STAY IN PLACE AT THE START OF THE LIFTING - IT WILL BE VERY NOTICEABLE TO THE USER OPERATOR OF THE SYSTEM BECAUSE THE PERSON IN THE SLING WILL IMMEDIATELY START LISTING TO ONE SIDE. HOWEVER IT HAS BEEN NOTED IN PREVIOUS EVENTS AND SIMULATED IN A CONTROLLED ENVIRONMENT, THAT IT CAN HAPPEN THAT THE PERSON IS NOT EVEN FULLY LIFTED FROM THE BED, BUT IN A MOMENT OF HASTE THE LIFT DEVICE IS PREMATURELY PULLED AWAY FROM THE BED. IF THAT HAPPENS WITH ALL CLIPS IN PLACE THERE MAY BE NO ISSUE, IF HOWEVER A CLIP WAS NOT IN PLACE THE PERSON IN THE SLING WILL DROP OUT OF THE SLING IMMEDIATELY. THE INSTRUCTIONS FOR USE (IFU) FOR LIFT INDICATES: ALWAYS CHECK THAT THE SLING ATTACHMENT CLIPS ARE FULLY IN POSITION BEFORE AND DURING THE COMMENCEMENT OF 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.

    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 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. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE RESIDENT TRANSFER ONE OF THE SLING CLIPS CAME LOOSE FROM THE SPREADER BAR OF THE TEMPO LIFT AND THE RESIDENT SLID OUT OF THE SLING FALLING ON THE FLOOR. AS A CONSEQUENCE OF THE EVENT THE RESIDENT SUSTAINED A LACERATION TO THE BACK OF THE HEAD WHICH REQUIRED STITCHES OR STAPLES TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432625 TEMPO TEMPO FSA ARJO MED AB LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other