BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX LOGICAL PRESSURE MONITORING KIT

    MDR report key: 2850032 · Received November 14, 2012

    Report

    Report Number
    2850032
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE PART OF THE TRANSDUCER, THE PLASTIC SINGLE USE "DOME" SHOULD HAVE AN AUDIBLE CLICK WHEN IT IS SEATED IN THE "BLOCK". THE DEVICE IS NOT CONSISTENTLY SEATING PROPERLY SO THE PRESSURE IS UNRELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX LOGICAL PRESSURE MONITORING KIT TRANSDUCER, BLOOD PRESSURE, EXTRAVASCULAR DRS SMITHS MEDICAL ASD, INC. * 2236110

    Patients

    Seq Age Sex Outcome Treatment
    1 *