BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONETIC

    MDR report key: 1612639 · Received February 12, 2010

    Report

    Report Number
    2031702-2010-00021
    Event Type
    Injury
    Date Received
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD MANY LOW MINUTE VOLUME ALARMS. THE RESPIRATORY THERAPIST ADVISED THE CAREGIVER TO MOVE THE PATIENT TO A NEW POSITION AND THE ALARM CLEARED. THE CAREGIVER REPORTED THE PATIENT WAS NOT IN DISTRESS AND WAS FINE. THE DOCTOR FOUND THE PATIENT'S BLOOD GASES TO BE "WAY OUT OF TOLERANCE" SO THE PATIENT WAS AIR-LIFTED TO A HOSPITAL FOR EVALUATION. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CAREFUSION 203, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization