BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAF-LIFT

    MDR report key: 2104024 · Received May 18, 2011

    Report

    Report Number
    1419652-2011-00121
    Event Type
    Death
    Date Received
    May 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ARJO, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARJOHUNTLEIGH SERVICE TECH ALSO STATED THAT THERE WAS NO CENTER STRAP ON THE SAF-LIFT CHAIR AND THAT THE CUSTOMER STATED THAT THEY WERE UNAWARE THAT IT WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    PER THE ARJOHUNTLEIGH SERVICE TECH: "CNA WAS NOT PRESENT AT TIME OF THIS INTERVIEW BUT ADMINISTRATOR, (B)(6) READ TO ME FROM HER WRITTEN STATEMENT THE FOLLOWING CNA, (NAME NOT RELEASED) HAD COMPLETED BATH ON RESIDENT AND HAD RAISED SAF-LIFT AND ROTATED AROUND TO OUTSIDE OF TUB AREA WHERE SHE LOWERED AND THEN STOPPED AND LOOSENED LAP STRAP ABOUT A HALF INCH BECAUSE RESIDENT WAS COMPLAINING THAT STRAP WAS TOO TIGHT AND WAS HURTING. CNA RETURNED TO LOWERING RESIDENT WHEN RESIDENT RAISED BOTH HER ARMS OVER HER HEAD AND LEANED HER HEAD BACK. AT THIS TIME RESIDENT SLID DOWN AND UNDER LAP BELT AND FELL TO FLOOR HITTING HER HEAD ON THE FLOOR. CNA IMMEDIATELY WENT TO RESIDENT'S AID AND ANOTHER CNA WALKED IN AT THIS TIME AND IMMEDIATELY WENT FOR HELP. THREE IN HOUSE NURSES RESPONDED AND ASKED FOR AN AMBULANCE TO BE CALLED. RESIDENT HAD OPEN WOUND TO HER HEAD AND WAS BLEEDING. (B)(6) STATED THAT RESIDENT WAS STILL RESPONSIVE WHEN EMS PUT HER IN AMBULANCE. RESIDENT WAS TAKEN TO MEDICAL CENTER OF (B)(6) EMERGENCY ROOM." THE RESIDENT HAD SUFFERED A LACERATION TO THE RIGHT SIDE OF THEIR HEAD AND A SKIN TEAR TO THEIR RIGHT ELBOW; IT WAS REPORTED THAT THEY PASSED AWAY AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-LIFT PATIENT LIFT FSA ARJO, INC. SL-10

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death