BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 3221052 · Received July 5, 2013

    Report

    Report Number
    1419652-2013-00187
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Report Date
    June 3, 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 COMPANY REP DESCRIPTION: "THE NEW ALENTI SAFETY BELT (CDA1450-035) IS NOT HOLDING. RECEIVED COMPLAINT ABOUT SAFETY BELT ON NEW ALENTI WITH SCALE. CUSTOMER NOTICED THE BELT WAS SLIPPING VERY EASY AND WANTED TO KNOW IF IT IS SAFE TO USE." REF MFR REPORT 9611530-2013-00079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307333 ALENTI FSA ARJO HOSPITAL EQUIPMENT AB CDB8153-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other