BEUDAMED
    FDA Adverse Event Other Summary report: N

    MK1 POOL LIFT

    MDR report key: 2774264 · Received September 23, 2012

    Report

    Report Number
    3007420694-2012-00040
    Event Type
    Other
    Date Received
    September 23, 2012
    Date of Event
    August 29, 2012
    Report Date
    August 30, 2012
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO MED (B)(4). 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 OR MEDIBO. AS OF 06/15/2010, THE (B)(4) NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER, THEN 07/16/2012, THE MEDIBO NUMBER WAS DE-ACTIVATED DUE TO SIMILAR REASONS. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HUNTLEIGH (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED. TREND REVIEW: AN MDR REVIEW WAS PERFORMED FOR THIS PRODUCT. THERE HAVE BEEN NO MDR'S INVOLVING AN MK1 POOL LIFT WITH A SIMILAR FAILURE TO DATE. OTHER MDR'S ARE NOT RELATED TO THIS FAILURE MODE. COMPLAINT REVIEW: NO OTHER COMPLAINTS WITH A SIMILAR FAILURE MODE WERE FOUND. THERE IS NO TREND OBSERVED FOR THIS FAILURE MODE FOR MK1 POOL LIFT DEVICE. THE PRODUCT SERIAL NUMBER (B)(4) WAS PRODUCED AND TESTED IN THE (B)(4) PRODUCTION FACILITY IN 1986 AND SUPPLIED TO MARLBOROUGH. THIS MEANS THAT THE DEVICE HAS BEEN IN USE FOR OVER 25 YEARS. ROOT CAUSE ANALYSIS: THE AVAILABLE PRODUCTS WERE NOT REQUESTED TO BE RETURNED FOR TESTING, SINCE THE PRODUCTS WERE ALREADY INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE SUFFICIENTLY CLEAR AND DETAILED FOR THIS INVESTIGATION. ON-SITE TEST OF THE PRODUCTS WITH THE CUSTOMER BY AN ARJOHUNTLEIGH TECHNICIAN WAS PERFORMED. IT WAS ESTABLISHED THAT: THE HOIST IN A GENERALLY POOR CONDITION, THE COLUMN CLAMP WAS INCORRECTLY FITTED AND DAMAGED. THE TRANSPORTER WAS FOUND TO BE IN A POOR CONDITION, WITH THE CLAMPS DAMAGED AND IN NEED OF REPLACING. ALL FUNCTIONS HOWEVER ARE WORKING FINE ON BOTH THE HOIST AND TRANSPORT. THE PICTURES PROVIDED WERE FOUND TO BE IN LINE WITH THE ARJOHUNTLEIGH TECHNICIAN'S FINDINGS AT THE CUSTOMER SITE. FURTHER PROBLEM CONFIRMATION WAS CARRIED OUT AS FOLLOWS: ACCORDING TO THE SERVICE TECHNICIAN: 'ALTHOUGH THE HOIST AND TRANSPORTER ARE IN A POOR CONDITION (AND REQUIRE WORK TO THEM), THE EVENT WAS CAUSED BY AN USE ERROR. WHEN I RECREATED THE EVENT, THE POOL HOIST WOULD HAVE TOPPLED INTO THE POOL, IF I HADN'T BEEN EXPECTING IT. THE ONLY POSSIBILITY FOR THIS HAPPENING, IS THAT THE USER HAD NOT LOCATED THE 5TH WHEEL INTO THE SLOT ON THE MAST, THEREFORE ALLOWING THE MAST AND BOOM TO ROTATE 90 DEGREES TOWARDS THE POOL (AS THERE IS QUITE A SUBSTANTIAL INCLINE ON POOLSIDE), WHEN IT WAS BEING RAISED OUT OF THE FLOOR SOCKET.' THE LIFT WAS FOUND TO BE IN LINE WITH THE SPECIFICATION, SO THE ROOT CAUSE OF THE EVENT IS CONSIDERED TO BE AN USE ERROR. A ROOT CAUSE ANALYSIS WAS PERFORMED USING A TOP-DOWN METHODOLOGY. NO TRAINING EVIDENCE WAS PROVIDED FOR THE STAFF INVOLVED. THE ROOT CAUSE OF THE EVENT IS CONSIDERED TO BE AN USE ERROR. FINAL CONCLUSIONS: WE HAVE BEEN ABLE TO DUPLICATE THE FAILURE MODE OF THIS COMPLAINT IN THEORY. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND WITH THIS PRODUCT AND ISSUE. WE HAVE FOUND THAT THE PRODUCT WAS UP TO SPEC WHEN THE EVENT OCCURRED. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. WE HAVE FOUND THAT THE LIFT WAS NOT USED FOR A POOLSIDE TRANSFER AT THE TIME OF THE EVENT. THE MOST PROBABLE ROOT CAUSE OF THE INCIDENT WAS FOUND TO BE THE USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER: 'THE POOL LIFT WAS BEING REMOVED FROM POOL SIDE BY CAREGIVER, USING THE TRANSPORTER, STAFF RAISED THE HOIST APPROX HALF WAY OUT OF THE FLOOR SOCKET, AS THIS WAS BEING DONE, THE BOOM AND MAST SWUNG AROUND OVER THE POOL, AND CAUSED THE HOIST AND THE TRANSPORTER TO TOPPLE INTO THE POOL.' NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MK1 POOL LIFT HYGIENE AND POOL LIFTERS FSA ARJO MED AB LTD. DA0542

    Patients

    Seq Age Sex Outcome Treatment
    1