BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK1 POOL LIFT

    MDR report key: 6197779 · Received December 22, 2016

    Report

    Report Number
    3007420694-2016-00260
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 5, 2016
    Report Date
    February 6, 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. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING REPORTABLE EVENTS FOR POOL LIFTS, WE HAVE NOT FOUND ANOTHER CASE WITH SIMILAR FAULT DESCRIPTION, THEREFORE WE CONSIDER THIS TO BE A SINGLE EVENT. AFTER THE ARJOHUNTLEIGH SERVICE TECHNICIAN INTERVIEW WITH THE CUSTOMER, IT WAS REVEALED THAT DURING THERAPY IN THE POOL, THE CHILD STARTED TO ROCK IN THE CHAIR CAUSING HER TO PLACE HER CHEEK IN THE WATER. OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU, DOCUMENT NUMBER DX10380.US ISSUE 3 FROM 2002 - THE EARLIEST AVAILABLE PRODUCT MANUAL THAT CAN BE REFERRED DUE TO NO MAJOR CHANGES IN PRODUCT DESIGN) PROVIDES INFORMATION ABOUT THE CORRECT USE OF THE POOL LIFT. IT INFORMS: "THE POOL LIFT MUST ONLY BE USED IN ACCORDANCE WITH THESE OPERATING INSTRUCTIONS. ANY PERSON USING THE POOL LIFT MUST FIRST READ AND UNDERSTAND THESE OPERATING INSTRUCTIONS" "WARNING: THERE SHOULD ALWAYS BE SOMEONE AT THE POOLSIDE COMPETENT TO OPERATE THE POOL LIFT WHILE THE PATIENT(S) ARE IN THE WATER." PROPER OPERATING TECHNIQUE IS PRESENTED AND SUPPORTED BY THE PICTURES. "NOTE: THIS UNIT MAY BE DETACHED FROM THE POOL LIFT ONCE IN THE WATER AND LOWERED SECURELY ONTO THE POOL FLOOR, PROVIDING THAT THE WATER DEPTH IS CORRECT FOR THE PATIENT." THIS COMPLAINT WAS DECIDED TO BE REPORTABLE IN ABUNDANCE OF CAUTION, DUE TO INITIAL INDICATION OF THE DEVICE TIPPING, WHAT COULD POTENTIALLY LEAD TO THE PATIENT'S FALL UNDER THE WATER TOGETHER WITH THE CHAIR. AFTER THE ADDITIONAL INFORMATION WAS PROVIDED, IT WAS REVEALED THAT THE CHAIR WAS ATTACHED TO THE BOOM ALL THE TIME. THE CHILD WAS MOVING AROUND IN THE CHAIR, AND FINALLY PUT THEIR CHEEK IN THE WATER. IT IS DEEMED ABNORMAL USE, AND THE RISK WAS MITIGATED BY PROFESSIONAL STAFF MEMBERS ATTENDING THE RESIDENT, AND BY USING A HARNESS PREVENTING FROM COMPLETE SLIPPING UNDER THE WATER. BASING ON THIS INFORMATION, WE DO NOT SEE THIS SITUATION TO BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WAS TO RECUR AND THEREFORE WE WILL NOT REPORT SIMILAR SITUATIONS IN THE FUTURE. THE DEVICE MET ITS SPECIFICATIONS; IT WAS BEING USED FOR PATIENT TREATMENT AT THE TIME OF THE EVENT AND BY THIS IT PLAYED A ROLE IN THE INCIDENT.

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

    Description of Event or Problem · 0

    ARJOHUNTLEIGH HAS BECAME AWARE OF THE COMPLAINT FOR MK1 POOL LIFT. INITIALLY, IT WAS REPORTED THAT THE POOL LIFT CHAIR WAS IN THE WATER AND A CHILD WAS BEING PLACED ON THE CHAIR. THE ASSISTANT IN THE WATER LIFTED THE CHAIR ARM OVER CAUSING THE CHAIR TO TIP SLIGHTLY. THE CHILD'S FACE SUBMERGED INTO THE POOL WATER SLIGHTLY. THE LIFE GUARD ASKED THE ASSISTANT TO LET GO OF THE ARM REST HANDLE AND RELEASE THE CHILD FROM THE CHAIR UN-CLIPPING A HARNESS THAT WAS IN USE ON THE POOL CHAIR. NO INJURY WAS REPORTED. AFTER CLARIFICATION, DIFFERENT SCENARIO OF EVENTS WAS REVEALED. THE SERVICE USER WAS PLACED ON THE SEAT WHILST IT WAS SUBMERGED IN THE WATER AND SECURED WITH A HARNESS. WHEN SECURED IN THE SEAT, THE SECURING ARM WAS PUT IN PLACE. THE USER STARTED TO ROCK IN THE CHAIR CAUSING HER TO PLACE HER CHEEK IN THE WATER. THE HARNESS WAS REMOVED AND THE USER REMOVED FROM THE POOL WITHOUT INCIDENT. THE CHAIR WAS PROPERLY ATTACHED TO THE BOOM ALL THE TIME.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH HAS BECAME AWARE OF THE COMPLAINT FOR MK1 POOL LIFT. IT WAS REPORTED THAT THE POOL LIFT CHAIR WAS IN THE WATER AND A CHILD WAS BEING PLACED ON THE CHAIR. THE ASSISTANT IN THE WATER LIFTED THE CHAIR ARM OVER CAUSING THE CHAIR TO TIP SLIGHTLY. THE CHILD'S FACE SUBMERGED INTO THE POOL WATER SLIGHTLY. THE LIFE GUARD ASKED THE ASSISTANT TO LET GO OF THE ARM REST HANDLE AND RELEASE THE CHILD FROM THE CHAIR UN-CLIPPING A HARNESS THAT WAS IN USE ON THE POOL CHAIR.NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848971 MK1 POOL LIFT LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other