BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATCHECK II

    MDR report key: 2233346 · Received August 30, 2011

    Report

    Report Number
    2233346
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 23, 2011
    Manufacturer
    VENT LAB
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AN INTUBATION WAS BEING PERFORMED IN THE ICU DEPARTMENT. THE RESPIRATORY THERAPIST WAS ASSISTING THE PHYSICIAN. THE RESPIRATORY THERAPIST (RT) STRUGGLED WITH THE DEVICE (NOT AWARE OF THE NEW PROCEDURE). SUBSEQUENTLY, THE ENTIRE COLIMETER TOWER CAME OFF AND IT TOOK UNNECESSARY TIME TO LEARN THE NEW APPLICATION AND COLOR CHANGE. THERE WERE APPARENTLY THREE EPISODES PRIOR TO STAFF BECOMING AWARE AND EDUCATED ABOUT THE CHANGE IN MODEL AND PROCEDURE. NOTIFICATION BY THE COMPANY DID NOT OCCUR, SO PROPER EDUCATION COULD TAKE PLACE PRIOR TO USE.======================MANUFACTURER RESPONSE FOR CO2 MONITORING DEVICE, CO2 RESUSACE (PER SITE REPORTER)======================VENT LAB: THE COMPANY MADE A MAJOR ANNOUNCEMENT ABOUT THESE CHANGES AND DIRECTED ALL THEIR DISTRIBUTORS, INCLUDING (B)(4) (OUR VENDOR) TO EDUCATE CUSTOMERS. APPARENTLY, THERE WAS A SIGNIFICANT CHANGE IN MANAGEMENT AT (B)(4) AT THE TIME, WHICH LEAD THEM TO NOT INFORMING THEIR CUSTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATCHECK II ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK VENT LAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES