BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALENTI

    MDR report key: 3003982 · Received March 12, 2013

    Report

    Report Number
    9611530-2013-00022
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    August 13, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH (B)(4). ON BEHALF OF THE IMPORTER (B)(4). CHECK OF ALENTI REPORTABLE COMPLAINTS HAS BEEN PERFORMED AND SHOWS 14 REPORTABLE EVENTS, WHERE THE SAFETY BELTS WERE NOT APPLIED AND THE PT FELL. WE WERE NOT ABLE TO FIND ANY DEFICIENCY WITH THE DEVICE. THIS MEANS THAT THE SHOWERING SYSTEM WAS UP TO SPEC WHEN THE EVENT TOOK PLACE. THE DEVICE WAS BEING USED FOR PT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM OUR EVAL, IT APPEARS A NUMBER OF USE ERRORS HAVE CAUSED THE EVENT, THE MOST RELEVANT USE ERROR BEING A FAILURE TO APPLY THE SAFETY BELTS TO THE PERSON AS IS STATED IN THE ALENTI INSTRUCTION FOR USE (04-.CD.02/7 US/CA): "[...] THE BELT IS DELIVERED WITH THE ALENTI AND MUST ALWAYS BE USED TO ENSURE THE LIFT IS USED AS INTENDED, I.E. THAT THE PT IS SITTING IN AN UPRIGHT POSITION. TO AVOID FALLING, MAKE SURE THAT THE RESIDENT IS POSITIONED CORRECTLY AND THAT THE SAFETY BELT IS BEING USE, PROPERLY FASTENED AND TIGHTENED. DIAGRAMS ARE USED IN THE LABELING TO SHOW THE CORRECT POSITION. THE PT HAS SLIPPED OUT OF THE ALENTI AND THIS HAS BEEN CAUSED BY NOT USING SAFETY BELT." THIS INCIDENT WAS CAUSED AS A RESULT OF NOT CORRECTLY FOLLOWING THE LABELLED HANDLING PROCEDURES AND INCORRECT PT ASSESSMENTS. NOTE THAT THE EVENT DESCRIPTION CLEARLY INDICATES THE BELT WAS NOT USED AS REQUIRED BY THE DEVICE LABELLING. THIS INDICATES THE EVENT WAS CAUSED BY USE ERROR. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS THE RECEIVED INFO AND OUR EVAL AS DESCRIBED ABOVE ARE SHOWING THAT IF THE IFU SAFETY WARNING ARE FOLLOWED THERE WILL BE NO PT TO CAREGIVER RISK.

    Description of Event or Problem · 1

    ACCORDING TO THE DETAILS INITIALLY REPORTED BY THE ARJOHUNTLEIGH REP 'IT WAS REPORTED THAT THE RESIDENT HAD WORN THE ALENTI SAFETY BELT THROUGHOUT THE BATHING PROCEDURE, RIGHT UP UNTIL THE POINT WHERE THE CAREGIVERS REMOVED THE BELT TO DRY OFF THE RESIDENT'S FRONT, WHILE THE RESIDENT WAS STILL ON THE SEAT AND LIFTED. THE RESIDENT STARTED TO SLIP OUT OF THE SEAT AND SINCE CAREGIVERS COULDN'T PHYSICALLY RELOCATE HER IN THE CHAIR THEY LOWERED HER TO THE FLOOR AND MADE A CALL. RESIDENT WAS NOT COMPLAINING OF PAIN AND WAS DECIDING TO GET UP.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103920 ALENTI HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB CDB8053-01

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death