BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3201897 · Received June 27, 2013

    Report

    Report Number
    1419652-2013-00174
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARJOHUNTLEIGH THAT WHEN BATH WAS FILLED, THE WATER STOPPED AT ITS INTENDED LEVEL, BUT THE SWIRLING DID NOT FUNCTION. PATIENT WAS GIVEN A REGULAR BATH. AFTER A SHORT WHILE, THE BATH STARTED TO RISE UNCOMMANDED AND KEPT RISING WHILE THE HYDROMASSAGE FUNCTION STARTED UP SIMULTANEOUSLY. THIS HAPPENED WHILE THE BATH WAS STILL IN USE. WHILE RISING, THE BATH PULLED UP THE BOLERO BATH LIFT AND THE PATIENT WHICH WAS ON THE LIFT. THE CAREGIVER IMMEDIATELY PUSHED A BUTTON, STOPPING THE BATH IN ITS UPWARD MOVEMENT. THE BUTTON NEEDED TO BE PRESSED CONTINUOUSLY TO PREVENT THE BATH TO RISE FURTHER. HOWEVER, IN ORDER TO FREE THE PATIENT FROM ITS PRECARIOUS SITUATION, THE PUSHBUTTON WAS RELEASED, RESULTING IN FURTHER RISING OF THE BATH TUB TO ITS HIGHEST POSITION. AT THIS POINT, THE FUSE OF THE HIGH-LOW MOTOR FAILED. SINCE THAT MOMENT, THE SHOWER HEAD PUSHBUTTON ON THE CONSOLE DID NOT FUNCTION ANYMORE. THE PATIENT WAS FREED WITHOUT ANY INJURIES OR FURTHER INCIDENT. REF MFR NUMBER: 9611530-2013-00068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293119 SYSTEM 2000 ILM ARJO HOSPITAL EQUIPMENT AB AP32801EI1010

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR