BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 2910285 · Received November 15, 2012

    Report

    Report Number
    9611530-2012-00199
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJO HOSPITAL EQUIPMENT (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: AS THE CAREGIVER WAS FILLING THE TUB AND JUST BEFORE THE WATER REACHED THE FILL LINE, THE TUB WIGGLED. THE CAREGIVER STOPPED THE FILL. THE TUB FELL FORWARD AND TO THE RIGHT. THERE WAS NO PT IN THE TUB DURING THIS TIME. THIS EVENT OCCURRED PRE-BATHING. THE THREADS WHERE THE BROKEN BOLT SCREWS INTO ARE STRIPPED, SO THEREFORE THE ENTIRE LOWER FRAME AND PILLARS ARE NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 2000 BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AR03311-US

    Patients

    Seq Age Sex Outcome Treatment
    1