BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD-PRIZM PCS II

    MDR report key: 3035483 · Received June 26, 2006

    Report

    Report Number
    3035483
    Event Type
    Injury
    Date Received
    June 26, 2006
    Date of Event
    June 1, 2006
    Report Date
    June 22, 2006
    Manufacturer
    SMITHS MEDICAL MD, DELTEC SYSTEMS INC.
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED UNRESPONSIVE BY FAMILY MEMBERS TO NURSING STAFF. PHYSICIAN WAS NOTIFIED BY NURSING STAFF AND ADMINISTERED NARCAN TO COUNTERACT THE EFFECT OF THE MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-PRIZM PCS II INFUSION PUMP, PCA MEA SMITHS MEDICAL MD, DELTEC SYSTEMS INC. 6101

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R