BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 3004062 · Received March 12, 2013

    Report

    Report Number
    9611530-2013-00018
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    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). THIS IS THE FIRST REPORTABLE EVENT FOR A SIMILAR FAILURE MODE AND THE DEVICE (ARM SUPPORT DROP CAUSING FRACTURES). THERE IS NO TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE ON ALENTI DEVICE. WE WERE NOT ABLE TO FIND ANY DEFICIENCY WITH THE DEVICE. THIS MEANS THAT THE SHOWERING SYSTEM WAS UP TO SPECIFICATION WHEN THE EVENT TOOK PLACE. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM OUR EVALUATION IT APPEARS A NUMBER OF USE ERRORS HAVE CAUSE THE EVENT, THE MOST RELEVANT USE ERROR BEING A FAILURE TO EVALUATE THE PERSON TO BE TRANSFERRED BEFORE USE: NEED FOR THE PROFESSIONAL CLINICAL ASSESSMENT PRIOR TO USE OF ALENTI DEVICE IS STATED IN THE INSTRUCTION FOR USE (04.CD.02/7 US/CA): 'WE RECOMMENDED THAT THE FACILITIES ESTABLISH REGULAR ASSESSMENT ROUTINES. CAREGIVERS SHOULD ASSESS EACH RESIDENT ACCORDING TO CRITERIA PRIOR TO USE [...], I.E. THE RESIDENT SHOULD UNDERSTAND AND RESPOND TO INSTRUCTIONS TO STAY SEATED IN AN UPRIGHT POSITION.' ADDITIONALLY IT IS WARNED: 'WARNING! WHEN POSITIONING THE LIFT HYGIENE CHAIR, DO NOT STAND IN THE DIRECTION OF THE MOVEMENT OF THE HAND REST. AN UNEXPECTED MOVEMENT OF THE ARMS UPWARDS, BY THE RESIDENT, CAN INJURY THE NURSE.' WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE IFU SAFETY WARNINGS ARE FOLLOWED THERE WILL BE NO PATIENT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    ACCORDING TO THE DETAILS REPORTED BY THE ARJOHUNTLIEGH REPRESENTATIVE, THE FOLLOWING OCCURRED: 'CAREGIVER ATTEMPTING TO GIVE BATH. RESIDENT WAS FINE GETTING INTO BATH, AS SOON AS WATER TURNED ON, HE FREAKED OUT SCREAMING AND YELLING AND FLUNG SAFETY BAR OF TUB CHAIR OFF WHICH LANDED ON SIDE OF LEFT WRIST OF CAREGIVER.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104077 ALENTI HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB CDB8153-01

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention