BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 1033130 · Received April 18, 2008

    Report

    Report Number
    9611530-2008-00021
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS A RIGHT-SIDE HEMIPLEGIC PATIENT WAS BEING TRANSFERRED ON THE LIFT CHAIR POSITIONED WITH HIS RIGHT SIDE BESIDE THE PILLAR. IN THE ATTEMPT TO MOVE THE LIFT CHAIR TOWARD THE TUB, IT WOULD NOT MOVE. A VISUAL CHECK OF THE LIFT CHAIR REVEALED THAT THE FRONT RIGHT CASTOR WAS SET IN A POSITION 90 DEGREES TO THE LEG OF THE LIFT CHAIR. AT THIS POINT, THE CAREGIVER HEARD A NOISE AND THE CASTOR CAME OFF THE LIFT CHAIR. THE LIFT CHAIR FELL ON THE CAREGIVER; THE RESIDENT TRIED TO GRAB A NEARBY GRAB BAR TO PREVENT THE FALL. THE CAREGIVER WAS EXAMINED BY A DOCTOR AND WAS REPORTED TO HAVE SUSTAINED SOFT TISSUE DAMAGE, RESULTING IN PAIN IN THE LEFT HIP AND BUTTOCK. THE RESIDENT WAS ASSESSED BY THE CHARGE NURSE AND REPORTED TO HAVE SUSTAINED CONTUSIONS AND ABRASIONS ON THE CHEST DOWN THE LOWER LEFT SIDE OF THE ABDOMEN AND HIP, AND A SMALL SKIN TEAR TO THE RIGHT ARM. INJURIES WERE PATCHED AND ICE ADMINISTERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other