BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADU5 ANESTHESIA MACHINE

    MDR report key: 753796 · Received August 8, 2006

    Report

    Report Number
    MW1039979
    Event Type
    Injury
    Date Received
    August 8, 2006
    Date of Event
    July 26, 2006
    Report Date
    August 7, 2006
    Manufacturer
    DATEK OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DATEK OHMEDA ADU5 ANESTHESIA MACHINE / VENTILLATOR IN USE DURING SURGICAL PROCEDURE- MEDISORB CANNISTER CO2 OBSORBER (GE HEALTHCARE) WAS DISCOVERED TO BE RESTRICTING GAS FLOW RESULTING IN HIGH PEAK INSPIRATORY PRESSURES. ALL MEDISORB CANNISTERS FROM LOT # 021056 WERE PULLED FROM STOCK AND RETURNED TO MANUFACTURER. UPON DISCOVER THE MEDISORB CANNISTER WAS CHANGED AND PROBLEM RESOLVED. NO HARM TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADU5 ANESTHESIA MACHINE * BSZ DATEK OHMEDA * *
    2 MEDISORB CANNISTER CO2 ABSORBER * BSF GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention