BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 2000

    MDR report key: 2592129 · Received May 23, 2012

    Report

    Report Number
    9611530-2012-00071
    Event Type
    Death
    Date Received
    May 23, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 25, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MFR ARJO (B)(4). THE MFR CONCLUDES: IT HAS COME TO OUR KNOWLEDGE THAT A PT PASSED AWAY IN A SYSTEM 2000 BATH. THIS IS A BATH THAT IS INTENDED FOR USE WITH EITHER A BATH CHAIR OR TROLLEY AND UNDER THE SUPERVISION OF TRAINED SKILLED NURSING STAFF IN ACCORDANCE TO THE INSTRUCTIONS FOR USE. THE USER IS INSTRUCTED TO ¿NEVER LEAVE THE RESIDENT UNATTENDED AT ANY TIME AND NEVER LET THE RESIDENT STAND UP IN THE BATH.¿ IT WOULD APPEAR THAT THE BATH WAS USED WITHOUT ANY SHOWER CHAIR OR TROLLEY AND THAT THE PT WAS LEFT UNATTENDED IN THE BATH FOR 45 MINUTES. THE COMBINATION OF THE BATH BEING USED WITHOUT A SHOWER CHAIR OR TROLLEY AND THAT THE FOOT SUPPORT WAS NOT USED MADE IT POSSIBLE FOR THE PT TO BE SUBMERGED. THIS BATH WAS NOT USED ACCORDING TO THE INSTRUCTIONS FOR USE. THE EVENT IS NOT LIKELY TO HAVE OCCURRED IF BATH HAD BEEN USED ACCORDING TO THE INTENDED USE. THE BATH HAS BEEN EXAMINED AND NO FAULT COULD BE FOUND. IT IS THE MFR¿S BELIEF THAT THE BATH DID NOT CONTRIBUTE TO THE EVENT. WE WILL NOT TAKE ANY FURTHER ACTIONS ON THIS EVENT BUT THE RECORD WILL BE KEPT FOR FUTURE TRENDING. IT COULD ALSO BE SEEN FROM PICTURES SENT TO MFR THAT ONE OF THE FOOTS OF THE BATH HAD COME LOOSE FROM ITS FIXATION TO THE FLOOR. THIS IS NOT BELIEVED TO HAVE CONTRIBUTED TO THE EVENT BUT IT IS RECOMMENDED TO REFASTEN THE FOOT TO THE FLOOR.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE CUSTOMER ON (B)(6) 2012: A FULLY ABLED LADY WANTED TO TAKE A BATH. APPROX 14.45 HRS. BATH WAS FILLED BY STAFF, APPROX 15.00 HRS. STAFF CHECKED TO SEE IF LADY WAS OK. APPROX 15.45 HRS. FRIENDS CAME TO VISIT AND SINCE SHE WAS NOT FOUND BY BEDSIDE NURSES WENT BACK TO BATH TO FIND HER SUBMERGED. THEY REMOVED HER FROM BATH AND TRIED TO RESUSCITATE BUT WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 2000 BATH SYSTEMS FSA ARJO HOSPITAL EQUIPMENT AB AR31801-GB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death