BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGM

    MDR report key: 1649631 · Received March 8, 2010

    Report

    Report Number
    1649631
    Event Type
    Malfunction
    Date Received
    March 8, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 8, 2010
    Manufacturer
    PHILIPS MEDICAL
    Product Code
    CBQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE WATERTRAP ON IT NEEDS TO BE REPLACED FREQUENTLY, MOST OF THE TIME THE MANIFOLD SEAL COMES OUT ATTACHED TO THE WATERTRAP. IT IS A LITTLE PIECE THAT IS NOT EASY TO SEE. THIS PRODUCES A LEAKAGE AND THE UNIT DOES NOT READ THE VALUE OF THE GAS MEASURED. WE CONTACTED PHILIP TO ADDRESS THIS ISSUE. MANUFACTURER RESPONSE (AS PER REPORTER) FOR ANESTHESIA GAS MODULE, PHILIPS AGMTHEY WILL LOOK INTO THIS COMPLAINT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGM ANESTHESIA GAS MODULE CBQ PHILIPS MEDICAL M1019A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *