BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICAP

    MDR report key: 3231730 · Received July 12, 2013

    Report

    Report Number
    2936999-2013-00502
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HE...
    Product Code
    CCK
    PMA / PMN Number
    K944400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (SECOND PEDICAP SEE 2936999-2013-00501).

    Description of Event or Problem · 1

    (B)(6) WITH RECURRENT APNEA SECONDARY TO NEC. IN THE AFTERNOON OF (B)(6), THE NEONATAL TEAM DETERMINED THAT THE PT NEEDED ENDOTRACHEAL INTUBATION FOR CONTINUED RESPIRATORY SUPPORT. IT WAS REPORTED TO COVIDIEN THAT THE PRODUCT DID NOT CHANGE COLOR. A SECOND ETCO2 DETECTOR (SAME BRAND AND LOT NUMBER AS THE FIRST) WAS USED WITH THE SAME RESULTS. USERS EXHALED THROUGH SAMPLE FROM LOT # 123210105X WITH NO COLOR CHANGE NOTED. A THIRD ETCO2 DETECTOR (SAME BRAND /DIFFERENT LOT) WAS USED, ENDOTRACHEAL INTUBATION WAS SUCCESSFUL. PT CONDITION WAS NOTED AS STABLE/CRITICAL BOTH BEFORE AND AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324792 PEDICAP PEDIATRIC END TIDAL C02 DETECTOR CCK COVIDIEN, FORMERLY TYCO HE... 123210105X

    Patients

    Seq Age Sex Outcome Treatment
    1 PRESSURE MONITOR, MODEL HS4051| VENTLAB HYPERFINLATION SYSTEM: FEATURING BUILT-IN