BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER BATH

    MDR report key: 2910205 · Received November 23, 2012

    Report

    Report Number
    9611530-2012-00214
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: BATH WAS LEAKING, BATH TUBE CAME LOOSE FROM THE CHASSIS. HAS BEEN GLUED. DOOR SEAL WAS ALSO LEAKING AND GAS STRUT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARKER BATH BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1