BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 1010496 · Received February 7, 2008

    Report

    Report Number
    1010496
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 7, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FROM OR. STOPCOCK ON DRIP LINE WAS BROKEN. WHITE OFF REGULATOR HAD COME OFF THE TOP OF THE STOPCOCK WHEN TURNED. PATIENT EXPERIENCED DRIP INTERRUPTION WHILE STOPCOCK CHANGED. FOUR HOURS LATER, SAME EVENTS OCCURRED WHILE TURNING THE WHITE PORTION OF STOPCOCK. PATIENT BLOOD PRESSURE DROPPED TO 55/30. PHYSICIAN AT BEDSIDE. VOLUME RESUSCITATION ADMINISTERED WHILE STOPCOCK CHANGED. PATIENT RECOVERED AFTER APPROXIMATELY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX STOPCOCK FMG SMITHS MEDICAL * 37J18D017

    Patients

    Seq Age Sex Outcome Treatment
    1 *