BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 600

    MDR report key: 6337687 · Received February 16, 2017

    Report

    Report Number
    9681684-2017-00012
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Report Date
    May 25, 2017
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT INDICATING THAT THE CEILING INSTALLATION RAIL SYSTEM KWIKTRACK RAIL SYSTEM (ON WHICH THE MAXI SKY 600 CEILING DEVICE IS INSTALLED) WAS UNSTABLE AND MAY POSE A RISK FOR A USER. FOLLOWING RECEIVED PHOTOGRAPHIC EVIDENCES, THERE WERE SLIGHT SCRAPING AROUND FIXING IN THE CEILING. THE TRACK INVOLVED IN THIS COMPLAINT IS LINEAR KWIKTRACK RAIL SUPPORTED BY ANCHOR POINTS. THE HARDWARE STRUCTURE USED TO ATTACH THESE ATTACHMENT POINTS WAS MADE OF STEEL. THE SYSTEM IS PLACED UNDER THE SUSPENDED CEILING. THE CUSTOMER FACILITY WAS VISITED BY THE ARJOHUNTLEIGH REPRESENTATIVE. IT WAS CONFIRMED THAT THE 5M RAIL, FIXED WITH THREADED RODS IS UNSTABLE. THERE WAS AN ABNORMAL MOVEMENT OF RAILS BALANCE IN THE DIRECTION OF THE LENGTH. IN LIGHT OF COLLECTED INFORMATION, DURING THE INSPECTION AT THE CUSTOMER FACILITY WE HAVE BEEN ABLE TO ESTABLISH THAT THE RAILS INSTABILITY WAS CAUSED BY PROGRESSIVE LOOSENING OF THE EXISTING HARDWARE INCLUDING A LATERAL BRACES (WHICH ARE INTENDED TO MINIMIZE BRACKET MOVEMENTS CAUSED BY PATIENT HANDLING AND TRANSFER). PLEASE BE AWARE THAT THE PROBLEM WAS RESOLVED BY RETIGHTENING CONNECTIONS. AFTER THAT, ALL CEILING INSTALLATIONS HAVE BEEN INSPECTED AND ALL OF THEM PASSED THE TEST. THE FOLLOWING ROOT CAUSES WERE ANALYZED: THE CEILING LIFT WAS USED TO TRANSFER PATIENTS WHOSE WEIGHT EXCEEDED THE SAFE WORKING LOAD OF THE INSTALLATION. THE INVOLVED CUSTOMER USES THE MAXI SKY 600 CEILING LIFTS WHICH ARE DEDICATED FOR KWIKTRAK RAIL SYSTEM. THIS CEILING LIFT HAS BEEN DESIGNED WITH A LIFTING CAPACITY OF 272 KG. OVERLOADING THE LIFT MAY CAUSE AN LOOSENING OF THE RAIL. BASED ON COLLECTED DATA WE CANNOT ASSESS WHETHER THE RECOMMENDED SWL WAS NOT EXCEEDED. THIS FACTOR CANNOT BE RULED OUT. THE MAINTENANCE OF THE TRACK WAS NOT PERFORMED ADEQUATELY AS SPECIFIED IN THE IFU. ACCORDING TO IFU FOR CEILING LIFT (MAXI SKY 600 001.14150.33 REV. 17) THE AUTHORIZED SERVICE TECHNICIAN SHOULD PERFORM YEARLY INSPECTIONS FOR KWIKTRAK RAILS. PLEASE NOTE THAT THE TECHNICAL MANUAL (FOR EXAMPLE: 001.14155.33 REV.7) DESCRIBES STEP BY STEP HOW CORRECTLY PERFORM THE INSPECTION. "THIS ANNUAL VERIFICATION SHOULD THE VERIFY THE FOLLOWING ASPECTS: - THE TRACK SYSTEM, INCLUDING ITS ANCHORS, ARE STILL PERFORMING AS INTENDED AND ARE SECURE. - THE UNIT IS ABLE TO MECHANICALLY RAISE THE SAFE WORKING LOAD." NOTE: "THE WEIGHT TO BE APPLIED MUST BE EQUIVALENT TO THE MAXIMUM CAPACITY OF THE TRACK." ABOVE HYPOTHESIS IS THE MOST PROBABLE. THE IFU OF THE DEVICE PRESENTS INSPECTION AND PREVENTIVE MAINTENANCE CHECKS WHICH WOULD DETECT FAILED COMPONENTS AND WOULD PREVENT THE PROGRESSIVE LOOSENING OF THE HARDWARE STRUCTURE. DURING INVESTIGATION WAS ESTABLISHED THAT THE LAST MAINTENANCE WAS PERFORMED IN SEPTEMBER 2016, ANY PROBLEMS WERE NOT NOTED. THEREFORE, IT CAN BE CONCLUDED THAT THE INSTALLATION WAS NOT PROPERLY INSPECTED AND MAINTAINED. IT WILL BE RECOMMENDED TO INFORM THE CUSTOMER THAT THE MAINTENANCE AND SWL TEST (SAFE WORKING LOAD) SHOULD BE PERFORMED YEARLY; THE AUTHORIZED SERVICE TECHNICIAN THAT DURING YEARLY MAINTENANCE SHOULD BE CONFIRMED THAT THE TRACK SYSTEM, INCLUDING ITS ANCHORS, ARE STILL PERFORMING AS INTENDED AND ARE SECURE, AND THAT THE UNIT IS ABLE TO MECHANICALLY RAISE THE SAFE WORKING LOAD. WHEN REVIEWING REPORTABLE COMPLAINTS RELATED TO INSTALLATION DEDICATED FOR UN-PORTABLE CEILING LIFTS REGISTERED DURING LAST 5 YEAR, THE GIVEN CIRCUMSTANCES (UNSTABLE RAILS DUE TO NOT TIGHT ENOUGH HARDWARE SYSTEM) AND THE SEQUENCE OF EVENT OF THIS PARTICULAR COMPLAINT APPEARS TO BE AN ISOLATED OCCURRENCE. IN SUMMARY, THE CEILING RAIL SYSTEM WAS NOT UP TO THE MANUFACTURER SPECIFICATION BECAUSE THE RAIL SYSTEM WAS UNSTABLE. THE COMPLAINT DECIDED TO BE REPORTABLE BASED ON ALLEGATION THAT THE INSTALLATION RAIL IS UNSTABLE AND THAT COULD POSE THE USER AT RISK, ALTHOUGH THAT THERE WERE NO INFORMATION ABOUT THE PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    ARJOHUNTLEIGH IS STILL IN THE PROCESS OF COLLECTING THE ADDITIONAL INFORMATION. STILL NOT SUFFICIENT DETAILS ARE AVAILABLE AT THE TIME OF WRITING THIS REPORT. FINAL REPORT WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT INDICATING THAT THE CEILING INSTALLATION RAIL SYSTEM KWIKTRACK RAIL SYSTEM (ON WHICH THE MAXI SKY 600 CEILING DEVICE IS INSTALLED) WAS UNSTABLE AND MAY POSE A RISK FOR A USER. FOLLOWING RECEIVED PHOTOGRAPHIC EVIDENCES, THERE WERE SLIGHT SCRAPING AROUND FIXING IN THE CEILING. THE TRACK INVOLVED IN THIS COMPLAINT IS LINEAR KWIKTRACK RAIL SUPPORTED BY ANCHOR POINTS. THE HARDWARE STRUCTURE USED TO ATTACH THESE ATTACHMENT POINTS WAS MADE OF STEEL. THE SYSTEM IS PLACED UNDER THE SUSPENDED CEILING. THE CUSTOMER FACILITY WAS VISITED BY THE ARJOHUNTLEIGH REPRESENTATIVE. IT WAS CONFIRMED THAT THE 5 M RAIL, FIXED WITH THREADED RODS IS UNSTABLE. THERE WAS AN ABNORMAL MOVEMENT OF RAILS BALANCE IN THE DIRECTION OF THE LENGTH.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT INDICATING THAT THE CEILING INSTALLATION RAIL SYSTEM WAS UNSTABLE AND MAY POSE A RISK FOR A USER. FOLLOWING PHOTOGRAPHIC EVIDENCES RECEIVED SO FAR, THERE WERE SLIGHT SCRAPING AROUND FIXING IN THE CEILING. ARJOHUNTLEIGH IS STILL IN THE PROCESS OF COLLECTING MORE INFORMATION FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120470 MAXI SKY 600 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other