BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 7384585 · Received March 30, 2018

    Report

    Report Number
    3007420694-2018-00077
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 5, 2018
    Report Date
    March 30, 2018
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER 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 SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION, WHEN THE MAXI MOVE PASSIVE FLOOR LIFT TILTED OR TIPPED OVER. ON 2018-03-05 ARJOHUNTLEIGH HAS BECOME AWARE OF AN EVENT WHICH OCCURRED WITH THE INVOLVEMENT OF A MAXI MOVE PASSIVE FLOOR LIFT AT CUSTOMER FACILITY LOCATED IN (B)(6), IT. IT WAS REPORTED THAT DURING THE PATIENT LATERAL TRANSFER, THE LIFT LOST ITS STABILITY AND TILTED OVER. AS A CONSEQUENCE THE DEVICE LEG FELL ON THE PATIENT'S LEG CAUSING A FINGER SOFT TISSUE INJURY. THE LIFT WAS INSPECTED BY ARJO REPRESENTATIVE AFTER THE EVENT- IT WAS FOUND IN GOOD GENERAL CONDITION. THE SERVICE TECHNICIAN TESTED THE DEVICE; ALL ITS FUNCTIONS WERE OPERATING ACCORDING TO ITS SPECIFICATION- NO MALFUNCTION WAS DETECTED. THE LAST PREVENTIVE MAINTENANCE OF THE DEVICE WAS PERFORMED ON 14-AUG-2017 BY ARJO SERVICE. PLEASE NOTE THAT OUR LIFT DEVICES FULFILL THE ISO 10535 REQUIREMENTS OF BEING STABLE WITH THE SAFE WORKING LOAD WEIGHT (SWL) IN THE MOST ADVERSE POSITION. AS REQUIRED PER ISO 10535 A STABILITY TEST WAS PERFORMED DURING THE DESIGN PHASE FOR MAXI MOVE DEVICE THAT PROVES THAT EVEN ON A TILTING SLOPE, WHEN LIFTING 1.25X THE SWL, AND IN THE MOST ADVERSE POSITION, THE DEVICE DOES NOT BECOME UNSTABLE. THE FACTOR AS THE STABILITY INHERENT TO THE DESIGN OF THE DEVICE AT THE TIME OF USE WAS NOT CONSIDERED AS CONTRIBUTING FACTOR TO THE EVENT. BASED ON PREVIOUS INVESTIGATIONS, THE FOLLOWING FACTORS ARE CONSIDERED TO BE THE POSSIBLE CAUSES OF LIFT TIPPING: A) APPLYING THE CHASSIS BRAKES WHILE ATTEMPTING TO MOVE THE DEVICE, B) USING OTHER THAN MANEUVERING HANDLE PARTS OF THE DEVICE TO MOVE IT, FOR EXAMPLE, THE MAST, THE JIB, THE SPREADER BAR OR THE PATIENT, C) PUSHING THE DEVICE DIRECTLY ON THE OBSTRUCTIONS ON THE FLOOR, D) PUSHING OR PULLING THE DEVICE SIDEWAY INSTEAD OF THE FRONT DIRECTION, E) MALFUNCTIONS OF THE LIFT OR THE SLING. THE MAXI MOVE OPERATING AND PRODUCT CARE INSTRUCTIONS (KRX21030.GB) WARN AND INFORM THE USER: "THE CHASSIS REAR CASTORS HAVE BRAKES WHICH CAN BE FOOT OPERATED WHEN REQUIRED (SEE FIG. 16). DO NOT APPLY THE CASTOR BRAKES AT THIS STAGE, AS THE POSITION OF THE PATIENT WILL ADJUST TO HIS/ HER OWN CENTER OF GRAVITY WHEN LIFTED." "IF REQUIRED, THE CHASSIS LEGS MAY BE OPENED TO MANEUVER AROUND A CHAIR OR WHEELCHAIR." "USING THE ADJUSTABLE WIDTH CHASSIS, IT IS POSSIBLE TO MAKE ADJUSTMENTS TO CHASSIS LEG WIDTHS TO ASSIST MANEUVERABILITY AROUND OBSTRUCTIONS, FOR EXAMPLE, BED LEGS. ACCORDING TO THE ARJO SERVICE TECHNICIAN STATEMENT LIFT LOST ITS STABILITY DUE TO THE FACT THAT CHASSIS LEGS OF THE DEVICE WERE NOT OPENED BY THE CAREGIVERS IN THE TIME WHEN THE EVENT OCCURRED - THE PATIENT WEIGHT WAS NOT WELL DISTRIBUTED. THIS SITUATION MIGHT HAVE DISRUPTED STABILITY OF THE LIFT AND, AS A CONSEQUENCE CAUSED THE DEVICE TIPPING. PLEASE NOTE THAT LIFT HAS BEEN IN USED FOR OVER 19 YEARS. LOOKING AT THE INCIDENT SCENARIO IT HAS BEEN ESTABLISHED THAT MAXI MOVE PASSIVE FLOOR LIFT WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY CONTRIBUTED TO THE REPORTABLE EVENT - DEVICE TIPPING OVER. NO TECHNICAL MALFUNCTION OF THE DEVICE WAS DETECTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO TIPPING AND FROM THAT PERSPECTIVE, THE FLOOR LIT DEVICE WAS UP TO ITS TECHNICAL SPECIFICATION AT THE TIME OF THE INCIDENT. NEVERTHELESS, THE DEVICE WAS REPORTED TO TIP AND IN THIS REGARD, THE FLOOR LIFT DID NOT MEET ITS PERFORMANCE SPECIFICATION. NO ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 0

    ON (B)(6) 2018 ARJOHUNTLEIGH HAS BECOME AWARE OF AN EVENT WHICH OCCURRED WITH THE INVOLVEMENT OF A MAXI MOVE PASSIVE FLOOR LIFT AT CUSTOMER FACILITY LOCATED IN (B)(6). IT WAS REPORTED THAT DURING THE PATIENT LATERAL TRANSFER, THE LIFT LOST ITS STABILITY AND TILTED OVER. AS A CONSEQUENCE THE DEVICE LEG FELL ON THE PATIENT'S LEG CAUSING A FINGER SOFT TISSUE INJURY. THE LIFT WAS INSPECTED BY ARJO REPRESENTATIVE AFTER THE EVENT- IT WAS FOUND IN GOOD GENERAL CONDITION. THE SERVICE TECHNICIAN TESTED THE DEVICE; ALL ITS FUNCTIONS WERE OPERATING ACCORDING TO ITS SPECIFICATION- NO MALFUNCTION WAS DETECTED. THE LAST PREVENTIVE MAINTENANCE OF THE DEVICE WAS PERFORMED ON (B)(6) 2017 BY ARJO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228189 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other