BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDICAP

    MDR report key: 962768 · Received December 11, 2007

    Report

    Report Number
    2936999-2007-00542
    Event Type
    Other
    Date Received
    December 11, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 28, 2007
    Manufacturer
    COVIDIEN
    Product Code
    CCK
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER UNCERTAIN OF THE LOT NUMBER OF DEVICE. THERE IS NO PRODUCT AVAILABLE FOR RETURN. REPORTER STATED THAT THE PT WAS HAVING PERFUSION ISSUES AND QUESTIONED IF THAT COULD ACCOUNT FOR FAILURE TO CHANGE COLOR. BY THE TIME THE PT WAS INTUBATED FOR THE THIRD TIME THE PT HAD BEEN VENTILATED FOR SEVERAL MINUTES AND PERFUSION WAS BEING ASSISTED WITH CHEST COMPRESSIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY IN 2007 THAT TWO DAYS EARLIER, THEY HAD INTUBATED A PT AND ATTACHED A PEDICAP TO VERIFY TRACHEAL INTUBATION. AFTER SIX BREATHS THE COLOR OF THE PEDICAP CHANGED FROM DARK PURPLE TO A LIGHTER PURPLE, BUT NEVER WENT TO TAN OR YELLOW. THE PT WAS EXTUBATED BASED ON NO COLOR CHANGE, REINTUBATED AND USING THE SAME PEDICAP DID NOT CHANGE COLOR. A DIFFERENT PEDICAP WAS USED AND IT STARTED CHANGING FROM PURPLE TO YELLOW AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICAP PEDIATRIC CO2 DETECTOR 6 CCK COVIDIEN PEDICAP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention