BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 2910186 · Received November 23, 2012

    Report

    Report Number
    9611530-2012-00205
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 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 EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER¿S INESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: RHAPSODY, COMPLAINT OF TUB UNSTABLE WHEN FULL. FOUND LOOSE LEG MOUNTING BOLT. REMOVE AND REINSTALL WITH LOCTITE, CHECK OTHER MOUNTING BOLTS. TEST WITH FULL OF WATER, OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 2000 BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AR33212-US

    Patients

    Seq Age Sex Outcome Treatment
    1