BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 3201491 · Received June 27, 2013

    Report

    Report Number
    9611530-2013-00059
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    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 SOME CASES WITH SIMILAR FAULT DESCRIPTION (ALENTI CASTORS GET LOOSE/FALL OFF), WHICH WERE FOUND TO MAINLY RELATE TO EVENTS CAUSED BY USE AND MAINTENANCE ERROR. THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE ON ALENTI DEVICE IS CONSIDERED TO BE LOW AND STABLE. THE ALENTI DEVICE WAS FOUND NOT TO BE UP TO SPECIFICATION AND WAS USED FOR PATIENT TRANSFER WHEN THE PROBLEM WAS DETECTED. AS A RESULT IT CAUSED OR CONTRIBUTED TO THE EVENT. FROM OUR EVAL IT APPEARS A USE AND MAINTENANCE ERROR MIGHT BE SUGGESTED TO HAVE CAUSED THE COMPLAINT: A FAILURE TO CHECK/CLEAN THE CASTORS. THE NEED FOR THIS CHECK/CLEAN/REPLACE IS CLEARLY STATED IN THE INSTRUCTIONS FOR USE (04.CD.02 REV 02 DATE JUNE 1998): 'CAREGIVER OBLIGATIONS' ARE REFERRING TO: DAILY: 'CLEANING', WEEKLY: 'CHECK THAT THE WHEEL ON THE LIFT HYGIENE CHAIR HAVE BEEN CLEANED'. PLEASE BE AWARE THAT THIS DEVICE IS MORE THAN 10 YEARS OLD AND ACCORDING TO THE IFU (04.CD.02REV02 DATE JUNE 1998): 'THE USEFUL LIFE OF THIS EQUIPMENT, UNLESS OTHERWISE STATED, IS TEN (10) YEARS, SUBJECT TO PREVENTATIVE MAINTENANCE BEING CARRIED OUT IN ACCORDANCE WITH THE INSTRUCTIONS FOR CARE AND MAINTENANCE.' WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR RELATING TO THE DEVICE'S MAINTENANCE AS THE RECEIVED INFO AND OUR EVAL AS DESCRIBED ABOVE ARE SHOWING THAT IF THE INSTRUCTIONS FOR USE SAFETY WARNINGS ARE FOLLOWED THERE WILL BE NO PATIENT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    REF IMPORTER NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292873 ALENTI NONE FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other