BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3964795 · Received June 25, 2014

    Report

    Report Number
    1419652-2014-00166
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY COMPANY REPRESENTATIVE THAT SMOKE WAS COMING FROM THE UNIT DURING USE: "A CLIENT WAS HAVING A SPA BATH WHEN A STAFF MEMBER NOTICED "SMOULDERING AND SMOKE" COMING FROM THE BATH. IT BECAME CLEAR THAT THE SPA HAD CAUGHT FIRE AND SO THE FIRE BRIGADE WAS CALLED IMMEDIATELY. THE FIRE CREW ARRIVED WITHIN 4 MINUTES AND EVACUATED THE FACILITY AND CONTAINED THE FIRE AND DE-COMMISSIONED THE BATH. THE CLIENT WAS TREATED BY A DOCTOR." REPORTED INCIDENT HAS BEEN CLARIFIED IN PROVIDED INCIDENT DESCRIPTION FORM (IDF): "CARER ENTERED THE ROOM AND FOUND IT WAS FILLING WITH SMOKE. THE STAFF MEMBER CALMLY HELPED THE CLIENT OUT OF THE BATH. NO FLAMES WERE REPORTED." FROM THE INFO REC'D NO INJURY OCCURRED TO THE PATIENT OR CAREGIVER. PATIENT WAS OBSERVED OVERNIGHT AND TAKEN TO THE DOCTOR NEXT DAY BUT NO LASTING EFFECTS. MFR REPORT #: 9611530-2014-00041.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370651 SYSTEM 2000 ILM ARJO HOSPITAL EQUIPMENT AB AP32801-EU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other