BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 2576412 · Received March 22, 2012

    Report

    Report Number
    2576412
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    September 25, 2011
    Report Date
    November 3, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    VENT ALARM SOUNDED TWICE, AND FLASHED (PT MOTION DID NOT SET OFF ALARM). THE ALARM READ EXT HIGH PEAK PRESSURE. RESPIRATORY THERAPIST HAD TO VENT THE PT WITH AN AMBU-BAG TO PREVENT PT HARM. RESPIRATORY THERAPIST CHECKED THE ALARM HISTORY, WHICH READ THIS ALARM AND MALFUNCTION HAD OCCURRED PREVIOUSLY ON THIS MACHINE. NO PT HARM OCCURRED BECAUSE OF RN INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION AVEA VENTILATOR CBK CAREFUSION 17310-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention