BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 1844272 · Received September 20, 2010

    Report

    Report Number
    1844272
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 6, 2010
    Manufacturer
    COVIDIEN PURITAN BENNET
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR MALFUNCTION. PATIENT WAS NOT GETTING FULL TIDAL VOLUME. PATIENT REMOVED FROM VENT & BAGGED UNTIL VENT COULD BE REPLACED. NO HARM TO PATIENT.======================HEALTH PROFESSIONAL'S IMPRESSION======================NO ADVERSE EVENT.TEST PERFORMEDPERFORMED FLOW SENSOR CALCULATION, ESTIMATED CALCULATION AND 100% CALCULATION. CHECK OK. NO PROBLEM FOUND. RESPIRATORY THERAPIST RAN SEVERAL TESTS WITH THE TEST LUNG, WITH TIDAL VOLUMES SHOWING ON SCREEN. RESPIRATORY THERAPIST WAS OK WITH UNIT. RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN PURITAN BENNET 840 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR