BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIRWAY MODULE

    MDR report key: 1913239 · Received November 26, 2010

    Report

    Report Number
    1913239
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    July 6, 2010
    Report Date
    November 26, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INTUBATION OF PATIENT, THE "GAS VAPOR ANALYZER" MALFUNCTIONED AND THERE WAS A 14 MINUTE DELAY IN SWITCHING IT OUT FOR A NEW MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT AIRWAY MODULE GAS MONITORING AND METABOLICS MODULE CCL GE HEALTHCARE E-CAIO *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO OTHER THERAPIES