BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTHETIC GAS MODULE

    MDR report key: 396955 · Received May 24, 2002

    Report

    Report Number
    9610816-2002-00082
    Event Type
    Malfunction
    Date Received
    May 24, 2002
    Date of Event
    April 26, 2002
    Report Date
    April 26, 2002
    Manufacturer
    PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH
    Product Code
    CBQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN USING WATER TRAP (MODEL M1657B) WITH THE AGM, THE CO2 WAVEFORM SHOWS A RISE DURING THE INSPIRATION CYCLE. THIS DID NOT OCCUR WITH THE PREVIOUS WATER TRAP MODEL. THE CUSTOMER NOTED THAT THIS EFFECT WAS EVIDENT WHEN PATIENT CIRCUIT PRESSURES EXCEED 26 CM H2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHETIC GAS MODULE AGM CBQ PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH M1026A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA