BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERLINE H

    MDR report key: 2061465 · Received April 1, 2011

    Report

    Report Number
    2061465
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    A SMALL PIECE OF THE PEDIPEDIATRIC-NEONATAL ETCO2 END TIDAL CO2 MONITOR (FOR INTUBATED CHILDREN) BROKE OFF AND GOT STUCK IN THE INFANT'S TRACHEOSTOMY TUBE. NURSE FOUND IT BEFORE HARM WAS CAUSED.======================MANUFACTURER RESPONSE FOR DISPOSABLE CANUAL, FILTERLINE H======================PHILLIPS IS CONCERNED AND WISHES TO EXAMINE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERLINE H DISPOSABLE CANUAL CCK PHILIPS HEALTHCARE M1923A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO NO OTHER THERAPIES