BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDHA ASTIVA ANESTHESIA MACHINE

    MDR report key: 380425 · Received February 28, 2002

    Report

    Report Number
    MW1024271
    Event Type
    Other
    Date Received
    February 28, 2002
    Date of Event
    November 18, 2000
    Report Date
    February 28, 2002
    Manufacturer
    DATEX-OMEDHA
    Product Code
    BSZ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON INDUCTION OF ANESTHESIA WITH NARCOTICS AND INTUBATING PT SUCCESSFULLY. ASTIVA ANESTHESIA MACHINE HAD GAS LEAK IN CO2 CANISTER DRAIN PLUG. REQUIRING USE OF AMBU BAG FOR SEVERAL MINS UNTIL DRAIN PLUG WAS IDENTIFIED AND TIGHTENED. PREVIOUSLY REPORT INCIDENT TO MFR WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDHA ASTIVA ANESTHESIA MACHINE GAS VENTILATOR BSZ DATEX-OMEDHA ASTEVA *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other