BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 3221019 · Received July 5, 2013

    Report

    Report Number
    1419652-2013-00182
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER'S DESCRIPTION: "WE RECEIVED THE NEW ALENTI LIFT LAST YEAR AND THE BELT THAT CAME WITH IT INITIALLY GOT BROKEN. WE ORDERED A NEW ONE AND RECEIVED IT IN (B)(6) 2012. THE STAFF DO NOT LIKE THIS NEW BELT AS THEY FIND THEY CAN'T TIGHTEN IT ENOUGH TO PREVENT THE RESIDENT FROM SLIPPING. SEVERAL STAFF MEMBERS HAVE TRIED TO FIGURE OUT HOW TO TIGHTEN IT SO THIS DOESN'T HAPPEN, BUT TO NO AVAIL. WE LIKED THE OLD BELT (NYLON MATERIAL, NOT RUBBER). I HAVE THE INSTRUCTIONS PAMPHLET BUT IT IS HARD TO UNDERSTAND. I'M THINKING WE NEED SOME KIND OF TRAINING ON ITS USE. THE TUB HAS BEEN PUT OUT OF USE UNTIL THIS PROBLEM CAN BE RESOLVED." REF MFR REPORT 9611530-2013-00074.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307465 ALENTI FSA ARJO HOSPITAL EQUIPMENT AB CDB8154-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other