BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMO

    MDR report key: 3140273 · Received May 24, 2013

    Report

    Report Number
    1419652-2013-00133
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED IN A PRIMO, A BATH SYSTEM FOR ASSISTED BATHING, AND IT WAS REPORTED FROM THE CUSTOMER; 'PATIENT HAD JUST BEEN REMOVED FROM THE BATH, A LARGE BANG WAS HEARD AND THE BATH TIPPED AND A LOT OF WATER DISPLACED ONTO THE FLOOR, BATH TAKEN OUT OF ACTION'. REF # 9611530-2013-00051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232354 PRIMO BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB ATB1202-01

    Patients

    Seq Age Sex Outcome Treatment
    1