BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 3140247 · Received May 24, 2013

    Report

    Report Number
    9611530-2013-00050
    Event Type
    Injury
    Date Received
    May 24, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (ALENTI TIP), WHICH WERE FOUND TO BE RELATED TO USER ERROR. (B)(4). WE ARE NOT ABLE TO FIND ANY DEFICIENCY WITH THE DEVICE, THE DEVICE WAS INSPECTED BY THE COMPANY REP AND WAS WORKING CORRECTLY. THE MAINTENANCE OF THIS DEVICE IS DONE BY ARJOHUNTLEIGH. THIS MEANS THAT THE LIFTING SYSTEM WAS UP TO SPECIFICATION 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 FOLLOW THE IFU IN USE. FROM THE IFU 04.CD.02 GB ISSUE 8 FROM JUNE 2004 AS SUPPLIED WITH THIS DEVICE: "RAISE THE ALENTI IF NECESSARY TO CLEAR THE EDGE OF THE BATH AND PULL IT AWAY FROM THE END OF THE BATH. HELP THE RESIDENT TO MOVE HIS/HER LEGS OVER THE EDGE OF THE BATH. MAKE SURE THE ALENTI IS COMPLETELY CLEAR FROM THE TUB AND OTHER DEVICES. LOWER THE RESIDENT TO A CONVENIENT HEIGHT." "WARNING! BEFORE LIFTING THE ALENTI OUT OF THE WATER AFTER A BATH, RE POSITION THE RESIDENT IF NEEDED TO ENSURE THAT THE RESIDENT IS SITTING UPRIGHT IN THE CENTRE OF THE CHAIR." "WARNING! NEVER LEAVE THE RESIDENT UNATTENDED AT ANY TIME, PARTICULARLY WHEN THE ALENTI IS IN A RAISED POSITION." "TO AVOID THE POSSIBILITY OF INJURY FROM TIPPING OR OTHER MISUSE, ALWAYS ENSURE THAT" THE EQUIPMENT IS USED BY APPROPRIATE TRAINED STAFF. THE ALENTI IS LOWERED TO ITS ERGONOMICALLY CORRECT HEIGHT DURING TRANSPORTATION. THE ALENTI IS LOWERED IMMEDIATELY AFTER REMOVING RESIDENTS FROM THE BATH AND THAT FOOTCARE IS PROVIDED WITH THE ALENTI IN A LOWERED POSITION. THE ALENTI IS MOVED WITH CARE, ESPECIALLY IN NARROW PASSAGES AND OVER UNEVEN SURFACES." 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 WARNINGS ARE FOLLOWED THERE WILL BE NO PT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231094 ALENTI HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization