BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 5111883 · Received September 29, 2015

    Report

    Report Number
    2936999-2015-00831
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    September 1, 2015
    Manufacturer
    COVIDIEN
    Product Code
    KHS
    PMA / PMN Number
    K944400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEDICAP PRODUCT WAS NOT CHANGING COLOR DESPITE CORRECT PLACEMENT HAVING BEEN CONFIRMED. THERE IS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642086 NELLCOR CARBON DIOXIDE (CO2) DETECTOR KHS COVIDIEN PEDICAP 140510002X

    Patients

    Seq Age Sex Outcome Treatment
    1