BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULIFT CLASSIC

    MDR report key: 6095908 · Received November 11, 2016

    Report

    Report Number
    3007420694-2016-00233
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    September 25, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ARJO MEDARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    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 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 DEACTIVATED 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. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR AMBULIFT, WE HAVE FOUND A LOW NUMBER OF SIMILAR CASES WHERE SEAT DETACHED FROM A JIB. THERE IS VERY LOW OCCURRENCE RATE FOR THIS KIND OF EVENTS. INITIALLY IT WAS REPORTED THAT THE CLIENT WAS BEING RAISED ON THE SEAT OF THE HOIST OUT OF THE BATH. THE HOIST WAS TURNED TO THE SIDE AND THE CLIENT FELL FROM THE HOIST ONTO THE FLOOR. AS REPORTED LATER, THE RESIDENT FELL TOGETHER WITH THE CHAIR WHEN THE CHAIR BECAME DETACHED FROM THE AMBULIFT. THE RESIDENT SUFFERED SOME BRUISING AS A RESULT OF THE INCIDENT. AMBULIFT IS A HYGIENIC, MOBILE PASSIVE LIFT, EQUIPPED WITH DETACHABLE SEAT THAT ALLOWS FOR RESIDENTS TRANSFER FROM BATH TO MOVABLE SUB-CHASSIS. THE CONNECTION BETWEEN SEAT AND HOIST CONSISTS OF THE CHAIR TUBE, WHICH IS PLACED INSIDE JIB PICK-UP HOOK AND IS CLOSED FROM THE TOP BY SAFETY CATCH. THIS CONNECTION SHOULD BE THOROUGHLY CHECKED EACH TIME IT IS USED. THE DEVICE WAS EXAMINED BY ARJOHUNTLEIGH REPRESENTATIVE WHO FOUND THAT THE JIB PICK-UP HOOK WAS BENT OUT OF SHAPE ALLOWING CHAIR TO DETACH FROM HOIST WITHOUT RELEASING SAFETY CATCH. THE INSTRUCTION FOR USE (IFU), WHICH IS PROVIDED WITH EACH DEVICE, INCLUDES INFORMATION ABOUT SAFE AND CORRECT USE OF THE PRODUCT. "TO TRANSFER THE PATIENT, ADJUST THE JIB HEIGHT USING THE CONTROL HANDSET SO THAT THE CHAIR HANDLE CAN ENGAGE IN THE CHAIR FRAME SUPPORT CHANNEL." "RAISE THE JIB SLIGHTLY TO ENSURE THE CHAIR RETAINING CATCH CLOSES. ALWAYS ENSURE THE CHAIR RETAINING CATCH ON THE JIB IS CLOSED WHEN THE CHAIR UNIT IS ATTACHED TO THE HOIST." "WARNING! ALWAYS ENSURE THE SEAT IS SECURE BEFORE ALLOWING A PATIENT TO USE IT." IFU INFORMS ALSO ABOUT NECESSARY CHECKS OF THE DEVICE CONDITION ON A REGULAR BASIS, THIS INCLUDES RETAINING CATCH. "THIS PRODUCT HAS BEEN DESIGNED AND MANUFACTURED TO PROVIDE YOU WITH MANY YEARS OF TROUBLE FREE USE, HOWEVER, THIS PRODUCT DOES CONTAIN COMPONENTS THAT WITH REGULAR USE ARE SUBJECT TO WEAR." "CHECKING THE CATCHES: RETAINING CATCHES ARE FITTED ON BOTH THE JIB AND THE TOILET/COMMODE/SHOWER CHAIR CHASSIS. BOTH ARE SPRING LOADED. THEY SHOULD BE CHECKED REGULARLY TO ENSURE THAT THEY FUNCTION CORRECTLY." PLEASE NOTE ALSO THAT THE INVOLVED DEVICE WAS IN USE FOR ABOUT 19 YEARS. IT WAS UNDER ARJO SERVICE CONTRACT UNTIL 2014, AND MAINTAINED BY A THIRD PARTY SINCE THEN. BUT ACCORDING TO EXCERPTS PRESENTED ABOVE, AND TAKING THE AGE OF THIS LIFT INTO CONSIDERATION, IT MIGHT BE ASSUMED THAT THESE ACTIVITIES WERE NOT FOLLOWED PER OUR RECOMMENDATIONS AND NOT SUFFICIENT TO ENSURE PATIENT'S SAFETY. THE RECEIVED INFORMATION SHOWED THAT THE JIB PICK-UP HOOK WAS DAMAGED, SO THE CHAIR COULD BE DETACHED FROM HOIST WITHOUT RELEASING IT, SO THE CHAIR COULD NOT BE SECURED ON THE HOIST. THEREFORE WE CONSIDER USER ERROR TO BE MOST RELATED: JIB PICK-UP HOOK DISTORTION WAS MOST LIKELY CAUSED BY A MISUSE. IT IS LIKELY THAT RETAINING CATCH ON THE JIB WAS NOT CLOSED CORRECTLY AND THE CAREGIVER DID NOT CHECK THIS ATTACHMENT. CAREGIVER DID NOT CHECK DEVICE CONDITION BEFORE USE AND USED IT WITH A RESIDENT WITH FAULTY CONNECTION. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR IN COMBINATION WITH WORN OUT EQUIPMENT AS THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE SAFETY WARNINGS WERE FOLLOWED IN ACCORDANCE TO PRODUCT INSTRUCTION FOR USE, THERE WOULD BE NO PATIENT OR CAREGIVER AT RISK. THE DEVICE WAS OUT OF THE MANUFACTURER'S SPECIFICATION. IT WAS USED FOR PATIENT CARE AND BY THIS CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSPECTION OF THE DEVICE ASSOCIATED WITH THE EVENT REVEALED THAT THE CHAIR HOOK BENT OUT OF SHAPE ALLOWING CHAIR TO DETACH FROM HOIST WITHOUT RELEASING SAFETY CATCH, WHEN CHAIR LOWERED ONTO STEEP SLOPING BATCH LOWER SECTION OF CHAIR IS LIFTED AWAY FROM GUIDE RAILS. ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    ON OCT 13TH 2016 THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH: THE RESIDENT WAS BEING RAISED ON THE SEAT OF THE HOIST OUT OF THE BATH. THE HOIST WAS TURNED TO THE SIDE AND THE CLIENT FELL FROM THE HOIST ONTO THE FLOOR. IT WAS REPORTED THAT THE RESIDENT SUFFERED BRUISING AS A RESULT OF THE INCIDENT, WHICH HAS NOT BEEN CLASSIFIED AS SERIOUS INJURY. THE HOIST HAS BEEN TAKEN OUT OF USE AND TAKEN TO (B)(6), WHERE IS NOW AWAITING AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748256 AMBULIFT CLASSIC NON-AC-POWERED PATIENT LIFT FSA ARJO MEDARJO MED. AB LTD. KDA0510-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other