BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 3030278 · Received March 28, 2013

    Report

    Report Number
    9681684-2013-00021
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    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 · 1

    (B)(4). A COMPLETE INVESTIGATION WAS PERFORMED BY THE MANUFACTURER, INCLUDING A REVIEW OF THE TREND OF SIMILAR PROBLEMS, HISTORY OF THE DEVICE INVOLVED AND SEQUENCE OF EVENTS. THERE IS A TREND OF LESS THAN THREE SIMILAR ADVERSE EVENTS IN AVERAGE PER YEAR WITH SIMILAR DEVICE AND THE OCCURRENCE RATE APPEARS TO BE LOW WHEN COMPARED TO THE AMOUNT OF TRANSFERS PERFORMED WITH THE ESTIMATED 54,700 DEVICE ON THE WORLDWIDE MARKET. NOTE THAT THE TREND REVIEW INCLUDES DIFFERENT SLING MODELS AND SPREADER BARS. A MORE SPECIFIC TREND REVIEW COULD NOT BE PERFORMED AS THE SLING MODEL WAS NOT REPORTED. THERE WERE NO RELEVANT TECHNICAL BULLETINS OR FIELD ACTIONS OR RELEVANT SERVICE HISTORY. AN A (B)(4) REPRESENTATIVE PERFORMED AN ONSITE VISIT AFTER THE INCIDENT. HE NOTED THAT THE FLOOR LIFT WAS EQUIPPED WITH A 2 POINT SPREADER BAR, WAS IN GOOD CONDITION AND UP TO SPECIFICATIONS. THE SLING LABEL WAS IN GOOD CONDITION AND IT DID NOT DETACH FROM THE SLING. IT WAS REPORTED BY THE FACILITY THAT THE SLING WAS PROPERLY APPLIED AND THE RESIDENT WAS IN AN ADEQUATE POSITION FOR THE TRANSFER. THE CAREGIVERS WERE PROPERLY TRAINED. THE RESIDENT SIMPLY MOVED FORWARD SUDDENLY AND WITH FORCE, RESULTING IN THE INCIDENT. THE FAMILY OF THE RESIDENT MENTIONED SIMILAR EVENTS HAD OCCURRED WITH THIS RESIDENT IN THE PAST. SINCE NO FAILURE TO MEET SPECIFICATION WAS REPORTED, NO PRODUCT RETURN WAS DEEMED NECESSARY. AS THE SEQUENCE OF EVENT WAS CLEAR AND UNDERSTOOD, NO SIMULATION WAS DEEMED NECESSARY. FROM THE SEQUENCE OF THE EVENTS, IT MUST BE NOTED THAT THE RESIDENT WAS BEING TRANSFERRED FROM THE SHOWER TO A WHEELCHAIR WITH THE FLOOR LIFT BY TWO CAREGIVERS. AS THE FLOOR LIFT WAS APPROACHING THE WHEELCHAIR, THE RESIDENT SUDDENLY AND VOLUNTARILY MOVED FORWARD WITH MOMENTUM, CAUSING THE RESIDENT'S FALL. THE RESIDENT HAD HER FEET IN THE SLING AND THE SLING REMAINED ATTACHED TO THE SPREADER BAR. THE ROOT CAUSE OF THE EVENT IS RELATED TO THE ACTION OF THE RESIDENT MOVING QUICKLY FORWARD AND WITH FORCE. IT HAS BEEN SUGGESTED TO REMIND THE FACILITY THAT SOME SLING APPLICATIONS METHODS AND SOME SLING MODELS ARE MORE APPROPRIATE THAN OTHERS IN REDUCING THE RISKS ASSOCIATED WITH AN AGITATED RESIDENT. PER EXAMPLE, WITH A 2 POINT SPREADER BAR, CROSSING THE SLING LEG STRAPS MAY BE MORE APPROPRIATE THAN A "LEGS OPENED" TYPE POSITION.

    Description of Event or Problem · 1

    THE SERVICE USER WAS BEEN HOISTED BACK INTO HER WHEELCHAIR FOLLOWING A SHOWER. STAFF HAD CONNECTED THE SLINGS, STARTED TO RAISE THE HOIST AND LOWERED THE SHOWER TRAY, RAISING THE SERVICE USER WITHIN THE SLING. THE HOIST WAS TURNED TO FACE THE WHEELCHAIR. DURING TRANSFER, THE SERVICE USER SUDDENLY AND VOLUNTARY MOVED FORWARD. THE SERVICE USER THEN FLIPPED FORWARD OUT OF THE SLING AND FELL TO THE FLOOR, SUSTAINED FACIAL DAMAGE (CUTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127258 OPERA MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD. KPA0300

    Patients

    Seq Age Sex Outcome Treatment
    1