BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY CAP II CO2 DETECTOR

    MDR report key: 886426 · Received July 27, 2007

    Report

    Report Number
    2936999-2007-00323
    Event Type
    Other
    Date Received
    July 27, 2007
    Date of Event
    July 15, 2007
    Report Date
    July 19, 2007
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CCK
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EASY CAP II WAS DISCARDED, THERE IS NO PRODUCT TO RETURN FOR EVALUATION. THE DIRECTIONS FOR USE STATES: WARNING: BEFORE USING THE EASY CAP II DETECTOR, READ COMPLETE DIRECTIONS FOR USE. INSTRUCTIONS FOR USE: REMOVE DETECTOR FROM POUCH AND IMMEDIATELY MATCH THE INITIAL COLOR OF THE INDICATOR TO THE PURPLE COLOR STRIPE LABELED CHECK AROUND THE DETECTOR WINDOW AS SHOWN IN A. USE THE DETECTOR ONLY IF THE PURPLE COLOR IF THE INDICATOR IS THE SAME COLOR OR DARKER THAN THE STRIPE MARKED CHECK. CAUTIONS: IN CARDIAC ARREST, RE-ESTABLISHMENT OF CARDIAC OUTPUT AND PULMONARY BLOOD FLOW BY ADEQUATE CPR IS NECESSARY TO INCREASE END-TIDAL CO2 TO LEVELS DETECTABLE BY THE EASY CAP II DETECTOR (ABOVE 0.5%). THE REPORTER STATES, THE COLOR OF THE DEVICE WAS NOT NOTED WHEN THE PACKAGE WAS OPENED. THE REPORTER ALSO STATES, THAT THEY STAPLE A FORM TO THE EASY CAP II FOIL POUCH, THUS COMPROMISING THE EASY CAP II FOR ITS INTENDED USE. THE EASY CAP II MAY BE USED FOR UP TO 2 HRS. THE PROPER USE OF THE DEVICE WAS DISCUSSED WITH THE REPORTER AND EDUCATIONAL MATERIALS SENT. THE REPORTER STATES THEY WILL STOP USING STAPLES TO ATTACH ANYTHING TO THE EASY CAP II.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NELLCOR PURITAN BENNETT ON 7/19/2007, THAT AN ADULT MALE PT DEVELOPED RESPIRATORY DISTRESS AND REQUIRED INTUBATION. ON THE FIRST ATTEMPT AT INTUBATION, THE ENDOTRACHEAL TUBE WAS DETERMINED TO BE IN THE ESOPHAGUS, BY AUSCULTATION AND EASY CAP II. THE ENDOTRACHEAL TUBE WAS PULLED BACK AND AT THE SECOND ATTEMPT AT INTUBATION, THE PT VOMITED AND THE EASY CAP II WAS CONTAMINATED WITH GASTRIC CONTENT. AFTER CLEARING THE AIRWAY, THE PT WAS SUCCESSFULLY INTUBATED AND A SECOND EASY CAP II WAS REMOVED FROM ITS PACKAGE AND APPLIED. THE COLOR OF THE EASY CAP II WAS NOT NOTED WHEN THE PACKAGE WAS OPENED. THE PT WAS VENTILATED USING A RESUSITATION BAG ATTACHED TO THE EASY CAP II. THE PT WENT INTO CARDIAC ARREST AND CPR WAS INITIATED ALMOST IMMEDIATELY. THE PT WAS VENTILATED INITIALLY AT A RATE OF 16 TO 20 BREATHS PER MINUTE THEN SLOWED TO A RATE OF ABOUT 12 AFTER ABOUT 10 MINS. AT SOME POINT WELL INTO THE CPR, IT WAS NOTED THAT THE EASY CAP II WAS YELLOW AND NOT CHANGING COLOR. AIR EXCHANGE APPEARED ADEQUATE. TUBE PLACEMENT WAS VERIFIED AGAIN BY AUSCULTATION. AFTER SEVERAL MINS, THE PT WAS DECLARED DEAD AND CPR WAS STOPPED. THE EASY CAP II WAS NOT SAVED, THERE IS NO PRODUCT AVAILABLE FOR RETURN FOR EVALUATION. DURING THE REPORT, THE REPORTER MADE MENTION, THAT THEY STAPLE A FORM TO THE EASY CAP II FOIL PACKAGE. IT WAS DISCUSSED WITH THE REPORTER THE CONSEQUENCE OF PIERCING THE FOIL POUCH AND EXPOSING THE EASYCAP II TO AIR, THUS COMPROMISING THE EASY CAP II FOR ITS INTENDED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CAP II CO2 DETECTOR CO2 DETECTOR CCK NELLCOR PURITAN BENNETT EASYCAP II 6296056

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention