BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTTER

    MDR report key: 7322886 · Received March 8, 2018

    Report

    Report Number
    3007420694-2018-00056
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 12, 2018
    Report Date
    April 6, 2018
    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. ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ON 2018-FEB-18 ARJOHUNTLEIGH WAS NOTIFIED ABOUT AN INCIDENT WITH THE INVOLVEMENT OF OTTER POOL LIFT, WHERE IT WAS REPORTED THAT WHILST LIFTING CHAIR OUT OF THE POOL, WITH THE INDIVIDUAL ON IT, THE CHAIR FELL INTO THE WATER. BASED ON THE COMPLAINT DESCRIPTION CAREGIVER, WHO WAS OPERATING THE DEVICE "FELT LIKE THE LIFT MISSED A COG". DURING THE EVENT CAREGIVERS TRIED TO GRAB THE CHAIR HANDLE TO STOP FALLING, BUT WERE UNABLE TO. THE INVOLVED INDIVIDUAL (CUSTOMER OF THE FACILITY) DID NOT SUSTAIN ANY INJURY, SO NO MEDICAL INTERVENTION WAS NECESSARY. THE DEVICE WAS TAKEN OUT OF SERVICE UNTIL REPAIRED. THE REVIEW OF SIMILAR REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE OTTER POOL LIFT IN LAST 5 YEARS, REVEALED A VERY LOW NUMBER OF CASES, WHERE LIFT CHAIR LOWERED ITSELF UNCOMMANDED. ON 2018-FEB-21 ARJOHUNTLEIGH REPRESENTATIVE VISITED THE CUSTOMER FACILITY TO PERFORM THE EVALUATION OF INVOLVED POOL LIFT AND INTERVIEW THE CUSTOMER FACILITY REPRESENTATIVE. BASED ON THE CONDUCTED INSPECTION THE LIFT WAS FOUND TO HAVE A CORROSION ON THE CHROME PARTS. THE LIFT WAS USED AT THE SWIMMING POOL AREA, THEREFORE, ENVIRONMENT WAS HUMID. MOREOVER, PAINT ON THE CHAIR HANDLE WAS MISSING AND LIFTING STRAP WAS COVERED WITH GREASE. IT WAS ALSO INDICATED THE CLUTCH MECHANISM WITHIN THE GEARBOX WAS FAULTY. THE ARJOHUNTLEIGH REPRESENTATIVE PERFORMED THE TEST WITH LOAD AND WITH RELEASED WINDING HANDLE. ACCORDING TO RESULTS, THE DEVICE DID NOT PASS THE TEST AS IT WAS LOWERING ITSELF THE INVOLVED OTTER LIFT WAS NOT UNDER ARJOHUNTLEIGH SERVICE CONTRACT AND WAS SERVICED BY 3RD PARTY CONTRACTOR ((B)(4) LTD). ACCORDING TO THE INFORMATION RECEIVED FROM THE CUSTOMER THE LIFT WAS SERVICED UNDER A CONTRACT COVERING A VISUAL LOLER INSPECTION FOLLOWED IN 6 MONTHS BY A LOLER LOAD TEST. THE PREVIOUS SERVICE WAS PERFORMED IN SEPTEMBER 2017 AND NEXT WAS PLANNED ON MARCH 2018 (BASED ON THE LABEL PUT ON THE DEVICE). THE SERVICE RECORDS WERE NOT AVAILABLE FOR ARJOHUNTLEIGH REPRESENTATIVE, SO IT REMAINS UNKNOWN WHETHER THE GEARBOX (WINCH MECHANISM) HAD BEEN EVER REPLACED OR SERVICED AS SUGGESTED IN THE DEVICE PREVENTIVE MAINTENANCE SCHEDULE [DX 27790.UK ISSUE 1] AND OPERATING INSTRUCTIONS [DX27750.GB.ISSUE-1]. BASED ON THE RECEIVED INFORMATION THE CLUTCH MECHANISM IN THE WINCH ASSEMBLY (GEARBOX) WAS FAULTY AND THE CHAIR WAS NOT ABLE TO REMAIN IN POSITION UNDER LOAD. ARJOHUNTLEIGH COULD NOT FURTHER INVESTIGATE THE WINCH MECHANISM TO DETERMINE FAULTS WITHIN THE ASSEMBLY, BECAUSE THE DEVICE WAS NOT UNDER A SERVICE CONTRACT (SERVICED BY 3RD PARTY (B)(4) LTD) AND THE CUSTOMER DID NOT MAKE THE PART AVAILABLE FOR ARJOHUNTLEIGH REPRESENTATIVE EVALUATION. HOWEVER, ACCORDING TO THE TECHNICIAN VISUAL DEVICE EVALUATION THE DEFECT OF WINCH MECHANISM COULD BE CAUSED BY NOT FOLLOWING PREVENTIVE MAINTENANCE PROCEDURES. UNFORTUNATELY, ARJOHUNTLEIGH WAS NOT CONTRACTED TO SERVICE THE INVOLVED DEVICE IT WAS NOT POSSIBLE TO VERIFY IF THE WINCH MECHANISM WAS EVER REPLACED AND SERVICE RECORDS WERE MAINTAINED BY MENTIONED 3RD PARTY. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER FACILITY REPRESENTATIVE THE LIFT WAS COVERED BY SERVICE CONTRACT COMPRISING OF A VISUAL LOLER INSPECTION FOLLOWED IN 6 MONTHS BY A LOLER LOAD TEST. THE THIRD PARTY SERVICE PROVIDER ALSO DID NOT PROVIDE DOCUMENTS OR PROCEDURES THEY FOLLOWED DURING SERVICE OF THE HOIST. THE OTTER OPERATING INSTRUCTIONS (IFU, VERSION ACTIVE AT THE TIME OF THE DISTRIBUTION OF THE INVOLVED DEVICE DX27750.GB.ISSUE-1 DATED ON APRIL 1998) INFORM HOW TO USE THE DEVICE CORRECTLY, INCLUDING CORRECT MAINTENANCE PROCEDURES TO BE FOLLOWED BY EACH DEVICE USER. BASED ON THE "GENERAL CONDITION" SECTION CUSTOMER USER SHOULD: "ENSURE THAT THE OTTER WILL SATISFACTORILY SUSTAIN A LOAD." (P. 6) MOREOVER TO THE SAME INSTRUCTIONS SAYS THE FOLLOWING: "A GENERAL VISUAL INSPECTION OF ALL EXTERNAL PARTS SHOULD BE CARRIED OUT PERIODICALLY AND ALL FUNCTIONS SHOULD BE TESTED FOR CORRECT OPERATION, TO ENSURE THAT NO ADVERSE DAMAGE HAS OCCURRED DURING USE. IF IN ANY DOUBT ABOUT THE CORRECT FUNCTIONING OF THE OTTER, WITHDRAW IT FROM USE AND CONTACT ARJO SERVICE DEPARTMENT." (P. 6) THE "SERVICE ADVICE" SECTION OF THE IFU ALSO PROVIDES INFORMATION ABOUT COMPONENTS CRITICAL TO THE SAFE OPERATION OF THE HOIST, WHICH MUST BE REGULARLY EXAMINED AND REPLACED AT THE SPECIFIED INTERVALS: "FRICTION DISCS (PARTS OF WINCH MECHANISM) - INSPECT EVERY 2 YEARS AND REPLACE IF NECESSARY.". PLEASE NOTE THAT OPERATING INSTRUCTIONS INFORM THAT TO MAINTAIN THE LIFT IN GOOD WORKING ORDER, IT IS RECOMMENDED TO HAVE IT METHODICALLY AND PROFESSIONALLY SERVICED BY AN ARJOHUNTLEIGH REPRESENTATIVE. THE PREVENTIVE MAINTENANCE SCHEDULE FOR OTTER POOL LIFT (PMS; DX 27790.UK ISSUE 1 DATED ON FEBRUARY 2001) INFORMS THAT: "EQUIPMENT OPERATORS AND SERVICE/MAINTENANCE PERSONNEL SHOULD HOLD THIS PREVENTIVE MAINTENANCE SCHEDULE." (P. 2) THE OTTER POOL LIFT IS SUBJECT TO WEAR AND TEAR, AND THE FOLLOWING MAINTENANCE INSTRUCTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE EQUIPMENT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION: "EVERY 2 YEARS: INSPECT THE FRICTION DISCS WITHIN THE WINCH HOUSING AND REPLACE IF NECESSARY. DUE TO THE COMPLEXITY OF THE WINCH HOUSING AND REQUIREMENTS FOR SETTING SLIP CLUTCHES, ARJO LTD RECOMMENDS A SERVICE EXCHANGE OF THE WINCH HOUSING." (PMS, P. 3) BASED ON THE COLLECTED INFORMATION THE INVOLVED DEVICE FAILED TO MEET THE MANUFACTURER'S SPECIFICATION. AT THE TIME OF THE EVENT THE DEVICE WAS USED FOR THERAPY OF THE INDIVIDUAL (FACILITY'S CUSTOMER). THIS ISSUE WAS REPORTED IN ABUNDANCE OF CAUTION DUE TO POTENTIAL FOR FALL OF THE PATIENT.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH WAS NOTIFIED ABOUT AN INCIDENT WITH INVOLVEMENT OF OTTER POOL LIFT, WHERE IT WAS REPORTED THAT WHILST LIFTING CHAIR OUT OF THE POOL, WITH THE INDIVIDUAL ON IT, THE CHAIR FELL INTO THE WATER. THE INVOLVED INDIVIDUAL DID NOT SUSTAIN ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168177 OTTER LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other