BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPO

    MDR report key: 5815158 · Received July 22, 2016

    Report

    Report Number
    3007420694-2016-00153
    Event Type
    Death
    Date Received
    July 22, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 14, 2016
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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 A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE RESIDENT TRANSFER FROM A BED ONE OF THE SHOULDER CLIP OF THE SLING DETACHED FROM THE SPREADER BAR OF THE TEMPO LIFT. IT WAS REPORTED THAT THE RESIDENT'S LEGS FELL OUT OF THE SLING AND THEN THE RESIDENT FELL TO THE FLOOR. AS A CONSEQUENCE OF THE EVENT, THE RESIDENT SUSTAINED BRUISING AND BROKEN RIGHT FEMUR. ADDITIONALLY, IT WAS INDICATED THAT THE RESIDENT WAS PLACED IN THE SLING INCORRECTLY WITH THE FEET WHERE THE HEAD SHOULD HAVE BEEN PLACED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. FOLLOWING THE INFORMATION RECEIVED IT IS MOST LIKELY THE RESIDENT WAS PLACED IN THE SLING INCORRECTLY WITH THE FEET WHERE THE HEAD SHOULD HAVE BEEN PLACED AND DURING THE PATIENT'S TRANSFER CLIP OF THE SLING DETACHED FROM THE SPREADER BAR OF TEMPO LIFT. AS A CONSEQUENCE OF THE EVENT THE PATIENT FELL DOWN. 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 RELATIVELY LOW AND STABLE. THE TEMPO LIFT AND THE SLING WERE INSPECTED AND NO MALFUNCTIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT CAN BE ESTABLISHED THAT THE SLING AND THE LIFT, WHICH WORK TOGETHER AS A SYSTEM, WERE FOUND TO HAVE BEEN UP TO SPECIFICATION, WHEN THE EVENT TOOK A PLACE AND WERE BEING USED FOR PATIENT HANDLING, BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO A USE ERROR. IT WAS INDICATED THAT ONE OF THE CLIP OF THE SLING DETACHED FROM THE SPREADER BAR DUE TO INCORRECT INSTALLATION OF THE SLING PROVIDED BY THE CAREGIVER. IN PARTICULAR: IT WAS INDICATED THAT THE STAFF WERE USING THE SLING UPSIDE DOWN, PUTTING THE HEAD END OF THE PATIENT AT THE FOOT AND OF THE SLING. IT APPEARS AS A RESULT THE PATIENT FELL OUT. IT IS POSSIBLE THAT DURING SUCH CIRCUMSTANCE A CLIP DETACHES WHEN NO LONGER UNDER TENSION BY THE WEIGHT OF THE PATIENT, HOWEVER IT IS NOT SEE AS THE CAUSE OF THE PATIENT DROPPING; 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. IF THE LABELLING IS FOLLOWED THERE CAN BE NO ISSUE. THE USER IS OBLIGED TO MONITOR THE CLIPS BECOMING UNDER TENSION WHEN THE WEIGHT OF THE PATIENT IS GRADUALLY BEING LOADED ON. THE SLING INSTRUCTION FOR USE (IFU) CURRENTLY USED 04.SC.000 INT1_2 CONTAINS CRUCIAL INFORMATION: "TO AVOID INJURY TO THE RESIDENT, PAY CLOSE ATTENTION WHEN LOWERING OR ADJUSTING THE SPREADER BAR." "TO AVOID THE RESIDENT FROM FALLING, MAKE SURE THAT THE SLING ATTACHMENTS ARE ATTACHED SECURELY BEFORE AND DURING THE LIFTING PROCESS." 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. ALSO, IT IS CLEARLY INDICATED IN THE LABELLING OF BOTH SLING AND THE LIFT DEVICE HOW TO DIFFERENTIATE THE HEAD FROM THE FOOT END AND HOW TO APPLY THE SLING TO THE PATIENT CORRECTLY. THIS INCLUDES DRAWINGS. FINALLY, THE LABELLING FOR THE LIFT DEVICE AND SLING INDICATE THE SYSTEM SHOULD BE USED BY TRAINED PERSONNEL THAT ARE AWARE OF THE IFU CONTENTS. WE COME TO THE ONE CONCLUSION, NAMELY THAT THERE WAS A USE ERROR THAT CAUSED THE EVENT. CONSEQUENTLY TO THE ABOVE, WE COME TO THE CONCLUSION THAT THE EVENT WAS MOST LIKELY CAUSED BY USE ERROR, BASED ON THE CUSTOMER INFORMATION AND THE SIMULATIONS PERFORMED PREVIOUSLY FOR PREVIOUS INCIDENTS. THE LABELLING FOR THE LIFT DEVICE INDICATES THE SYSTEM SHOULD BE USED BY TRAINED PERSONNEL THAT ARE AWARE OF THE IFU CONTENTS. NOTE THAT THE CUSTOMER WAS VISITED AND INTERVIEWED BY A LOCAL ARJOHUNTLEIGH REPRESENTATIVE. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT LIFTING PROCEDURE AND CHECK THE SLING BEFORE TRANSFER. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Description of Event or Problem · 1

    ON 25 JUL 2016 ARJOHUNTLEIGH HAS BEEN NOTIFIED THE RESIDENT INVOLVED IN FALL HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469762 TEMPO TEMPO FSA ARJO MED AB LTD KPA5000

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death| H