BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK1 POOL LIFT

    MDR report key: 2110999 · Received April 7, 2011

    Report

    Report Number
    3004468271-2011-00017
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POOL HOIST BOLTS, MAST INC SAFETY CATCH AND BOTTOM OF BOOM AROUND THE FLOOR SOCKET ARE HEAVILY RUSTED. POOL HOIST SUB CHASSIS AND SEAT HAS NORMAL WEAR AND TEAR WITH ONLY SURFACE RUST INSIDE THE SOCKETS OF THE ARM RESTS. PRODUCT NOT UNDER SERVICE CONTRACT.

    Description of Event or Problem · 1

    CARE GIVER WAS HOISTING RESIDENT OUT OF THE POOL. ONCE OUT OF THE POOL, THE BOOM ARM WAS TURNED AROUND PARALLEL TO THE EDGE OF THE POOL. CARE GIVER THEN DIS-ENGAGED THE CHAIR FROM THE POOL HOIST AND STARTED TO PUSH IT FORWARD, AT THIS POINT THE FRONT LEFT CASTOR (LOOKING FROM THE BACK OF THE SUB CHASSIS CHAIR) FELL OFF CAUSING THE CHAIR TO FALL SIDE WAYS TIPPING RESIDENT OUT. RESIDENT HIT THE SIDE OF THE POOL AS HE FEEL OUT AND ENDED UP BACK IN THE WATER. SWIMMING TEACHER, WHO WAS WALKING AWAY FROM THE HOIST AT THE TIME TURNED AROUND AND JUMPED INTO THE WATER TO RESCUE RESIDENT, WHO WAS THEN TAKEN TO A+E FOR ATTENTION. RESIDENT SUFFERED BRUISING TO HIS CHEST AREA AND RIGHT KNEE, AND ALSO HAD CUTS ON THE MIDDLE OF HIS CHEST, RIGHT ARM AND RIGHT KNUCKLE. DISCHARGED AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MK1 POOL LIFT HYGIENE AND POOL LIFTERS FSA MEDIBO MEDICAL PRODUCTS NV AX06100.0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other