BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIBU

    MDR report key: 1952241 · Received October 12, 2010

    Report

    Report Number
    9611530-2010-00075
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: "THE LADY WAS BATHING HERSELF WITH THE CHAIR OUTSIDE THE TUB. THE CHAIR THEN PICKED ITSELF UP AND LOWERED ONTO THE LADY IN THE BATH. THE LADY WAS BRUISED AND FRIGHTENED. THE BATH IS NOW TURNED OFF AS IT KEEPS OPERATING BY ITSELF." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU BATH, HYDRO-MASSAGE ILJ ARJO HOSPITAL EQUIPMENT AB AZR23110-GB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR