BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 5666124 · Received May 19, 2016

    Report

    Report Number
    3007420694-2016-00092
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 22, 2016
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. IT WAS REPORTED THAT DURING TRANSFER THE SPREADER BAR DETACHED FROM THE JIB CAUSING THE RESIDENT TO FALL TO THE BED. THE HANGER BAR FELL ON HER CAUSING BRUISING. THE RESIDENT BEGAN TO HYPERVENTILATE. OXYGEN WAS APPLIED AND RESIDENT CALMED DOWN AFTER 3-5 MINUTES. THE TREATMENT CONSISTED OF ICE APPLIED TO RESIDENT'S RIGHT FOREARM AND PRN TYLENOL FOR PAIN. X-RAYS OF FOREARM WERE OBTAINED THE FOLLOWING DAY. THE RESIDENT WAS NOT HOSPITALIZED. AFTER REVIEW OF THE REPORTABLE COMPLAINTS FOR TEMPO AND OPERA (AS THEIR DESIGN IS VERY SIMILAR), A LIMITED NUMBER OF CASES WAS FOUND WHERE THE T-BAR HAS BROKEN OFF THE LIFTING ARM. AFTER DETAILED REVISION OF EACH PREVIOUS CASE IT COULD BE STATED THAT ALL OF THE DEVICES HAD DIFFERENT SOLUTION OF JIB AND MAST CONNECTION, THEREFORE WE CONSIDER THIS CASE OF FAILED WELD IN PART KPX15220.20 AS ISOLATED. COMPARED TO THE AMOUNT OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USE, AMOUNT OF REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW AND STABLE. THE DEVICE WAS EXAMINED BY ARJOHUNTLEIGH REPRESENTATIVE AFTER THE EVENT. THE OVERALL VISUAL CONDITION OF THE LIFT WAS GOOD, THE LIFT FUNCTIONS: UP, DOWN AND CHASSIS LEGS WERE FUNCTIONAL. THE FRONT END SCALE PIVOT (PART NO. KPX15220.20) ATTACHING HANGER BAR TO SCALE LOAD CELL AND JIB ASSEMBLY COMPLETELY SEPARATED AT THE WELDS. THE FAILURE WAS CONFIRMED BY PHOTOGRAPHIC DOCUMENTATION. ACTUAL DEVICE COULD NOT BE EXAMINED AT THE MANUFACTURER BECAUSE THE DEVICE WAS NOT AVAILABLE FOR RETURN DESPITE OUR BEST EFFORTS. THE INVESTIGATED TEMPO DEVICE HAS PASSED ITS EXPECTED OPERATIONAL LIFETIME WITH 1,5 YEARS OVER THAT LIFETIME AT THE TIME OF THE INCIDENT. THE MAINTENANCE SERVICE HAS BEEN PERFORMED BY THE CUSTOMER THEMSELVES, BUT NO DATE OF THE LAST MAINTENANCE WAS PROVIDED. ALSO PREVENTIVE MAINTENANCE SCHEDULE WAS NOT AVAILABLE FOR THE CUSTOMER AND THEREFORE IT IS UNKNOWN WHAT WAS THE SCOPE OF MAINTENANCE PERFORMED BY THE FACILITY. THE INSTRUCTION FOR USE (IFU KPX50550.GB ISSUE 5 DATED ON NOVEMBER 2003), WHICH WAS PROVIDED WITH THE DEVICE, PRESENTS THE OBLIGATION OF THE PRODUCT CARE: "THE EXPECTED OPERATIONAL LIFE OF YOUR ARJO LIFTER IS 10 (TEN) YEARS FROM THE DATE OF MANUFACTURE PROVIDING THE FOLLOWING CONDITIONS ARE ADHERED TO:- THE UNIT IS CARED FOR AND SERVICED IN ACCORDANCE WITH RECOMMENDED, PUBLISHED "OPERATING AND PRODUCT CARE INSTRUCTIONS" AND THE "PREVENTIVE MAINTENANCE SCHEDULE". THE UNIT IS MAINTAINED TO THE MINIMUM REQUIREMENTS AS PUBLISHED IN THE "PREVENTIVE MAINTENANCE SCHEDULE". THE SERVICING AND PRODUCT CARE, IN ACCORDANCE WITH ARJO REQUIREMENTS, MUST BEGIN ON FIRST USE OF THE UNIT BY THE CUSTOMER." THERE ARE SEVERAL FACTORS THAT COULD CONTRIBUTE TO A DETERIORATION OF THE WELD. DEVICE BEING USED OVER ITS INTENDED LIFETIME: THE DEVICE IS VERIFIED AND VALIDATED TO PERFORM SAFELY AND CORRECTLY DURING THE LIFETIME INDICATED ON ITS LABELLING. THE DEVICE OFFERS THIS PERFORMANCE WHEN USED ACCORDING TO THE USE CONDITIONS DESCRIBED IN THE LABELLING (I.E. CORRECT USE PER IFU) INCLUDING THE CONDITION THAT IT IS MAINTAINED ACCORDING TO THE PREVENTIVE MAINTENANCE SCHEDULE SUPPLIED WITH THE DEVICE. WE COULD ACTUALLY STOP HERE AS IT IS CLEAR EVEN WITHOUT PRODUCT RETURN THAT THE DEVICE EXCEEDED THIS LABELLED LIFETIME AND THERE ARE INDICATIONS IT WAS NOT MAINTAINED AS PER LABELLING SINCE THERE WAS NO DATE OF LAST MAINTENANCE THAT COULD BE PROVIDED. FOR TRANSPARENCY, WE ALSO CAN SHARE THAT THERE ARE THE FOLLOWING POTENTIAL - ADDITIONAL - CAUSES FOR THE WELD BREAKAGE IN THIS CASE: ANOMALIES IN THE WELDING; THIS POTENTIAL ROOT CAUSE COULD NEITHER BE CONFIRMED NOR REJECTED DUE TO THE FACT THAT THE PART WAS NOT AVAILABLE FOR RETURN. OVERLOADING. HORIZONTAL FORCES APPLIED TO THE T-BAR CAUSED FOR EXAMPLE BY MANEUVERING BY PULLING OR PUSHING ON THE SPREADER BAR, WHICH IS CONTRARY TO THE INSTRUCTION FOR USE. NOTE THAT SUCH A FAILURES OF THE WELD ARE NOT LIKELY TO APPEAR SUDDENLY, BUT RATHER DEVELOP FOR A LONGER PERIOD OF TIME. THE JIB IS CRITICAL ELEMENT OF THE LIFT, NEEDS TO BE THOROUGHLY INSPECTED AND IT IS VERY PROBABLE THAT PROPER MAINTENANCE COULD PREVENT THE FAILURE. TO SUM UP, THE EXACT ROOT CAUSE CANNOT BE DEFINED WITH CERTAINTY SINCE THE DEVICE COULD NOT BE EXAMINED AT THE MANUFACTURER BECAUSE THE DEVICE WAS NOT AVAILABLE FOR RETURN, DESPITE OUR BEST EFFORTS. HOWEVER OUR INVESTIGATION SHOWS THAT THE DEVICE HAS BEEN USED 1.5 YEARS LONGER THAN IT WAS DESIGNED AND LABELLED FOR, AND THE USE CONDITIONS WITH REGARDS TO PERIODIC MAINTENANCE APPEARS NOT TO HAVE BEEN FOLLOWED. IT WILL BE RECOMMENDED TO THE CUSTOMER TO BE VIGILANT WITH REGARDS TO ANY ISSUES WITH THE DEVICE AND TO CONSIDER EXCLUDING THIS DEVICE FROM USE. THE DEVICE FAILED TO MEET ITS SPECIFICATIONS; IT WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY PLAYED A ROLE IN THE EVENT OUTCOME.

    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. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RESIDENT WAS BEING PUT IN BED WITH THE TEMPO LIFT IN ASSISTANCE OF TWO CAREGIVERS. AS SOON AS THE RESIDENT WAS POSITIONED OVER THE BED, THE COMPLETE HANGER BAR LET GO FROM THE JIB. THE RESIDENT FELL ON THE BED AND THE HANGER BAR FELL ON HER CAUSING BRUISING. THE RESIDENT BEGAN TO HYPERVENTILATE. OXYGEN WAS APPLIED AND RESIDENT CALMED DOWN AFTER 3-5 MINUTES. THE TREATMENT CONSISTED OF ICE APPLIED TO RESIDENT'S RIGHT FOREARM, PRN TYLENOL FOR PAIN. X-RAYS OF FOREARM WERE TO OBTAINED THE FOLLOWING DAY. THE RESIDENT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321600 TEMPO FSA FSA ARJO MED. AB LTD. KPA5010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other