BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 5764496 · Received July 1, 2016

    Report

    Report Number
    3007420694-2016-00119
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    May 31, 2016
    Report Date
    June 1, 2016
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO ED. 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. IT WAS REPORTED THAT THE RESIDENT WAS BEING TRANSFERRED FROM WHEELCHAIR TO POOL TROLLEY WHEN THE JIB DETACHED FROM THE LIFT. THE RESIDENT FELL 3-4 FEET TO THE FLOOR. NO INJURY WAS REPORTED. AFTER REVIEW OF THE REPORTABLE COMPLAINTS FOR OPERA, A LIMITED NUMBER OF SIMILAR CASES WERE FOUND WHERE THE T-BAR WERE REPORTED TO HAVE BECOME BROKEN OFF THE LIFTING ARM. DETAILED INVESTIGATIONS OF EACH CASE SHOWED THAT NO SYSTEMATIC CAUSE HAS BEEN DETERMINED. COMPARED TO THE AMOUNT OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USE AMOUNT OF REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW AND STABLE. THE DEVICE HAS BEEN EXAMINED BY AN ARJOHUNTLEIGH TECHNICIAN. THE CONDITION OF THE LIFT WAS ASSESSED AS "FAIR TO POOR". PHOTOGRAPHIC DOCUMENTATION CONFIRMED MANY SCRATCHES, DENTS AND PAINT PEELING. MARKS OF THE WATER INGRESS AND RUST COULD BE NOTICED. THE POLYURETHANE SKIN IN THE UPPER PART SEEMS TO HAVE BEEN DAMAGED BEFORE JIB BREAKAGE - IT CAN BE CONCLUDED FROM THE RUSTY-ORANGE COLORED DIRT PENETRATING TORN BLUE MATERIAL. THE TECHNICIAN PERFORMED LEG AND MAST FUNCTION TEST AND THEY WERE WORKING WELL. THE OPERATING MANUAL WAS NOT AVAILABLE TO THE USER, AS WELL AS PREVENTIVE MAINTENANCE SCHEDULE. THE DEVICE WAS NOT UNDER AN ARJO SERVICE CONTRACT AND THE DATE OF THE LAST MAINTENANCE IS UNKNOWN. BASING ON THE SERIAL NUMBER OF THE DEVICE IT IS KNOWN THAT IT HAS PASSED ITS EXPECTED OPERATIONAL LIFE ALMOST TWO YEARS BEFORE THE EVENT. THE INSTRUCTION FOR USE (IFU KPX01700.GB ISSUE 3 DATED ON APRIL 2003), WHICH WAS PROVIDED WITH THE DEVICE, PRESENTS THE CUSTOMER'S OBLIGATION OF THE PRODUCT CARE. THERE ARE SEVERAL FACTORS THAT COULD CONTRIBUTE DEVELOPING CRACK IN THE JIB, LIKE OVERLOADING, USING THE DEVICE IN WET AREAS OR HORIZONTAL FORCES APPLIED TO THE T-BAR (LIKE HITTING THE DOOR FRAMES), WHICH COULD CAUSE VISIBLE BENDING OF THE T-BAR. ALTHOUGH IN THE INVESTIGATED CASE NO SUCH A SINGLE ROOT CAUSE CAN BE CONFIRMED, THE RUSTY-ORANGE COLORED DIRT PENETRATING TORN BLUE MATERIAL COULD INDICATE SOME WATER INGRESS UNDER THE POLYURETHANE SKIN, WHICH MIGHT LEAD TO CORROSION AND WEAKENING OF THE MATERIAL. SUCH A CRACK IS NOT LIKELY TO APPEAR SUDDENLY, BUT RATHER DEVELOP FOR A LONGER PERIOD OF TIME. THERE COULD BE SOME INDICATIONS OF THE JIB FAILURE, LIKE DAMAGED POLYURETHANE SKIN OR T-BAR WHICH WAS NOT VERTICAL. THE JIB IS CRITICAL ELEMENT OF THE LIFT, NEEDS TO BE THOROUGHLY INSPECTED AND IT IS VERY PROBABLE THAT PROPER MAINTENANCE COULD PREVENT THE FAILURE. TO SUM UP, ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINED WITH CERTAINTY, THIS UNFORTUNATE EVENT WAS MOST LIKELY CAUSED AS A RESULT OF NEGLECTING SYSTEMIC MAINTENANCE (INDICATED IN THE INSTRUCTIONS FOR USE AND PREVENTIVE MAINTENANCE SCHEDULE) OF THE DEVICE THAT IN ADDITION EXCEEDED ITS EXPECTED OPERATIONAL LIFETIME WHICH IS 10 YEARS. AS ALREADY DISCUSSED WITH THE CUSTOMER, DUE TO THE FACT OF THE POOR CONDITION OF THE OPERA, IT WOULD NOT BE REPAIRED AND SHOULD HAVE BEEN EXCLUDED FROM USE. THE DEVICE FAILED TO MEET ITS SPECIFICATIONS; IT WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY PLAYED A ROLE IN THE EVENT OUTCOME.

    Description of Event or Problem · 0

    PATIENT WAS BEING TRANSFERRED FROM WHEELCHAIR TO POOL TROLLEY WHEN THE HANGER BAR DETACHED, CAUSING THE PATIENT TO FALL 3-4 FEET TO THE FLOOR. NO INJURIES WERE REPORTED, X-RAYS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418568 OPERA FSA FSA ARJO MED. AB LTD. KPA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other