BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 3111053 · Received April 19, 2013

    Report

    Report Number
    9611530-2013-00037
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (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 BE UP TO SPECIFICATION AND WAS USED FOR PT TRANSFER WHEN THE PROBLEM WAS DETECTED. AS A RESULT, IT CAUSED OR CONTRIBUTED TO THE EVENT. FROM OUR EVALUATION, IT APPEARS A USE AND MAINTENANCE ERROR APPEARS MIGHT BE SUGGESTED TO HAVE CAUSED THE COMPLAINT: A FAILURE TO CHECK/REPLACE THE CASTORS. THE NEED FOR THIS CHECK/CLEAN/REPLACE IS CLEARLY STATED IN THE INSTRUCTIONS FOR USE. (04.CD.05): 'CAREGIVER OBLIGATIONS' ARE REFERRING TO: EVERY WEEK: 'CHECK/CLEAN CASTORS'. 'QUALIFIED PERSONNEL ACTIONS' ARE REFERRING TO: EVERY YEAR: 'CHECK/REPLACE CASTORS'.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170201 ALENTI HYGIENE AND POOL LIFTERS ILS ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1