BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK1 POOL LIFT

    MDR report key: 6867917 · Received September 15, 2017

    Report

    Report Number
    3007420694-2017-00192
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 15, 2017
    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 · 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 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. MK1 POOL LIFT IS LEGACY PRODUCT. THE POOL LIFT IS A STATIONARY LIFT THAT HAS TO BE MOUNTED IN OR ONTO THE POOLSIDE FLOOR BEFORE RESIDENT TRANSFER. IT HAS BEEN DESIGNED TO TRANSFER RESIDENTS FROM THE POOLSIDE INTO THE POOL AND THE OTHER WAY AROUND, USING A CHAIR OR STRETCHER THAT HAS BEEN SPECIALLY DESIGNED FOR THE POOL LIFT. IN THE REPORTED COMPLAINT THE POOL LIFT WAS EQUIPPED WITH DETACHABLE SWIM CHAIR. IT WAS REPORTED THAT A MEMBER OF PUBLIC (FEMALE) FELL INTO THE WATER FROM THE POOL LIFT CHAIR BECAUSE A CHAIR BECAME DETACHED FROM THE HOIST. AS A RESULT SHE RECEIVED BRUISES TO THE LEFT THIGH. THERE WAS NO A SERIOUS INJURY SUSTAINED IN RELATION TO THIS INCIDENT. THE USER COMPLAINED THAT WAS FEELING UNSTEADY ON THE SEAT, SO SHE WAS REMOVED AND THE CHAIR WAS RESEATED. THE CUSTOMER STATED THAT ALTHOUGH THE SEAT HAD BEEN INCORRECTLY ATTACHED PREVIOUSLY, THIS HAD BEEN CORRECTED BEFORE USE WITH THE USER. DEVICE WAS EVALUATED BY ARJOHUNTLEIGH TECHNICIAN WHO CONCLUDED THAT THE HOIST WAS IN A POOR CONDITION AND REQUIRED A NEW MAST ASSEMBLY DUE TO CORROSION, HOWEVER THE DEVICE STILL OPERATED CORRECTLY, THE CHAIR AND MAST CATCH OPERATED PER MANUFACTURER SPECIFICATION. OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU, DOCUMENT NUMBER DX10380.GB ISSUE 3 DATED OCTOBER 2002) PROVIDES INFORMATION AND PICTOGRAPHIC SIGNS WHICH INSTRUCT HOW TO USE THE POOL LIFT. IT INFORMS AND WARNS: WARNING: "ADJUST THE HEIGHT OF THE MAST SO THAT THE HOOK UP POINT (WITH RETAINING CATCH) CAN BE POSITIONED UNDER THE TOP OF THE CHAIR OR STRETCHER SUPPORT FRAME. THE TOP OF THE SUPPORT FRAME MUST BE FULLY ENCLOSED BY THE SUPPORT CUP AND THE RETAINING CATCH MUST HAVE OPERATED TO RETAIN THE FRAME TUBE." WARNING: "THERE SHOULD ALWAYS BE SOMEONE AT THE POOLSIDE COMPETENT TO OPERATE THE POOL LIFT WHILE THE PATIENT(S) IS IN THE WATER." IN SECTION: "CARE OF YOUR POOL LIFT" THE DOCUMENT INDICATES : "CHECK THAT THE CHAIR/STRETCHER RETAINING CATCH OPERATES SATISFACTORILY AND THAT THE SPRING PRESSURE WITHIN THE CATCH IS MAINTAINED." TO SUM UP, NO FAULT WITHIN THE DEVICE WAS FOUND THAT COULD HAVE LED TO THE REPORTED INCIDENT. DURING THE ARJOHUNTLEIGH REPRESENTATIVE VISIT THE RECOMMENDATION WAS TO PROVIDE ADDITIONAL PRODUCT TRAINING REGARDING OPERATION OF THE POOL LIFT. FROM THE ABOVE, IT CAN BE STATED THAT THE USE ERROR CANNOT BE EXCLUDED, THE RECOMMENDATION GIVEN TO THE CUSTOMER SUGGESTS THAT A HUMAN FACTOR MAY BE ONE OF THE POSSIBLE ROOT CAUSE OF THE INCIDENT, THIS HOWEVER CANNOT BE DETERMINED WITH CERTAINTY. MK 1 POOL LIFT FAILED TO MEET ITS PERFORMANCE SPECIFICATION, HOWEVER IT DID NOT FAIL TO MEET MANUFACTURER'S SPECIFICATION - NO FAULT WITHIN THE DEVICE WAS FOUND. THIS DEVICE WAS USED FOR USER HYGIENE AT THE TIME OF EVENT AND FOR THIS REASON WAS DIRECTLY INVOLVED IN THE REPORTED INCIDENT. ALTHOUGH THERE WAS NO SERIOUS INJURY SUSTAINED, WE REPORT THIS EVENT IN ABUNDANCE OF CAUTION SINCE THE FALL FROM THE DEVICE CAN RESULT IN INJURY OF HIGH SEVERITY TO THE USER.

    Description of Event or Problem · 0

    A MEMBER OF PUBLIC (FEMALE) FELL INTO THE WATER FROM POOL CHAIR ATTACHED TO POOL HOIST. THE USER COMPLAINED THAT WAS FEELING UNSTEADY ON THE SEAT, SO SHE WAS REMOVED AND THE CHAIR WAS RESEATED. THE CHAIR WAS SWUNG OVER THE POOL AND IN THAT MOMENT IT BECAME DETACHED FROM THE HOIST DROPPING THE USER IN TO THE POOL. THE USER RECEIVED BRUISING TO THE LEFT THIGH, WHICH WAS TREATED WITH ICE-PACK. THERE WAS NO A SERIOUS INJURY IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651037 MK1 POOL LIFT LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other