BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2915259 · Received December 18, 2012

    Report

    Report Number
    2915259
    Date Received
    December 18, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CCL
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE EXTERNAL ANALYZER WAS FOUND READING 21% WITH THE VENTILATOR SET AT 40%. DISCOVERED WHEN THE CLINICIAN CARING FOR THE PATIENT NOTED THAT THE PATIENT'S OXYGEN SATURATION DID NOT RESPOND AS ANTICIPATED WITH AN INCREASE IN FIO2. THE VENT WAS IMMEDIATELY DISCONTINUED FROM USE AND SECURED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ANALYZER, GAS CCL CAREFUSION BBV03010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR