BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE RPA600 HEAVY DUTY LIFTER

    MDR report key: 1060677 · Received June 12, 2008

    Report

    Report Number
    MW5007292
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 12, 2008
    Manufacturer
    INVACARE
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS RESIDENT WAS BEING TRANSFERRED WITH A HOYER LIFT - INVACARE HEAVY DUTY- WHEN THE SLING LOOP POPPED OFF THE HOOK. AFTER INVESTIGATION OF THIS OCCURRENCE, IT WAS DISCOVERED -AFTER A PHONE CALL TO INVACARE- THAT THE PARTICULAR HANGER ARM HAD BEEN RECALLED BACK IN MAY OF 2006. WE ORDERED THIS HOYER LIFT ON 4/26/2006, IT WAS DELIVERED TO OUR FACILITY IN 2006. WE WERE NEVER NOTIFIED OF A PROBLEM WITH THIS PRODUCT, AND THIS RESIDENT SUSTAINED A CLAVICLE FRACTURE BECAUSE OF THE PRODUCT. WHEN OUR FACILITY ADMINISTRATOR CALLED INVACARE, THEY ASKED HIM DIRECTLY IF WE HAD BEEN "NOTIFIED" OF THE SWITCH TO A DIFFERENT HANGER BAR. WHEN HE REPLIED "NO", THEY WERE QUICK TO APOLOGIZE TO HIM, AND RECOMMENDED HE "BUY A NEW BAR IMMEDIATELY" --- THEY ALSO POINTED OUT THAT WE PURCHASED THE PRODUCT RIGHT AT THE TIME OF THE CHANGE OVER, AND IT MUST HAVE BEEN AN OVERSIGHT. AS DIRECTOR OF NURSING FOR A LONG TERM CARE FACILITY, I AM VERY UPSET BY THIS PRODUCT FAILURE SINCE ONE OF OUR RESIDENTS WAS INJURED DUE TO FAILURE. DATES OF USE: 2006-2008. DIAGNOSIS OR REASON FOR USE: "TOTAL DEPENCE FOR ALL TRANSFERS". EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE RPA600 HEAVY DUTY LIFTER HOYER LIFT FSA INVACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other