BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALENTI

    MDR report key: 599749 · Received May 6, 2005

    Report

    Report Number
    9611530-2005-00007
    Event Type
    Death
    Date Received
    May 6, 2005
    Date of Event
    October 28, 2004
    Report Date
    May 3, 2005
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE RESIDENT WAS BATHED AND REMOVED FROM THE TUB USING THE LIFT. THE RESIDENT AND LIFT WERE PARKED WITHOUT THE BRAKES ENGAGED APPROXIMATELY 12 INCHES FROM THE END OF THE TUB. THE RESIDENT WAS THEN DRIED IN THIS LCOATION. THE CAREGIVER TURNED AROUND TO "LOWER THE TUB AND OPEN THE DRAIN TO EMPTY THE TUB." WHEN THE CAREGIVER TURNED AROUND, THE RESIDENT WAS FACE DOWN ON THE FLOOR, ATTACHED TO THE LIFT. THE CAREGIVER DID NOT SEE THE LIFT AND RESIDENT FALL OVER. THE SAFETLY BELT WAS APPLIED "FROM THE FRONT, BETWEEN THE RESIDENT'S LEGS" WITH THE TIGHTENING MECHANISM AT THE BACK OF THE RESIDENT (AT ABOUT THE LOWER SPINE). THE RESIDENT INCURRED BRUISES ON BOTH KNEES, FRACTURES OF ONE FEMUR, AND A HEAD INJURY (BRUISING). THE RESIDENT WAS PLACED UNDER SEDATION. THE RESIDENT PASSED WAY THE NEXT DAY.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT WAS BATHED AND REMOVED FROM THE TUB USING THE LIFT. THE RESIDENT AND LIFT WERE PARKED WITHOUT THE BRAKES ENGAGED APPROX 12 INCHES FROM THE END OF THE TUB. THE RESIDENT WAS THEN DIRED IN THIS LOCATION. THE CAREGIVER TURNED AROUND TO "LOWER THE TUB AND OPEN THE DRAIN TO EMPTY THE TUB." WHEN THE CAREGIVER TURNED AROUND, THE RESIDENT WAS FACE DOWN ON THE FLOOR, ATTACHED TO THE LIFT. THE CAREGIVER DID NOT SEE THE LIFT AND RESIDENT FALL OVER. THE SAFETY BELT WAS APPLIED "FROM THE FRONT, BETWEEN THE RESIDENT'S LEGS" WITH THE TIGHETENING MECHANISM AT THE BACK OF THE RESIDENT (AT ABOUT THE LOWER SPINE). THE RESIDENT INCURRED BRUISES ON BOTH KNEES, FRACTURES OF ONE FEMUR, AND A HEAD INJURY (BRUISING). THE RESIDENT WAS PLACED UNDER SEDATION. THE RESIDENT PASSED AWAY 10/29/04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI PATIENT LIFT FSA ARJO HOSPITAL EQUIPMENT AB CDBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death