BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 3000

    MDR report key: 558920 · Received November 15, 2004

    Report

    Report Number
    558920
    Event Type
    Malfunction
    Date Received
    November 15, 2004
    Date of Event
    November 2, 2004
    Report Date
    November 15, 2004
    Manufacturer
    DATEX OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    NITROUS OXIDE HIGH PRESSURE REGULATOR ON DATEX OHMEDA 3000 ANESTHESIA MACHINE FAILED CAUSING HIGH PRESSURE TO ENTER SYSTEM WHEN TANK WAS TURNED ON. BIOMED HAS FOUND THIS FAILURE ON 2 UNITS THIS MONTH. FOLLOW UP TEST REVEALS:HIGH PRESSURE REGULATOR WAS TESTED PER AESTIVA SERVICE MANUAL PROCEDURES. PRESSURE WAS CONSISTANTLY HIGH OFTEN TOO HIGH FOR TEST SETUP BEING USED. WHEN NEW REGULATORS WERE INSTALLED BOTH MACHINES TESTED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA 3000 ANESTHESIA MACHINE BSZ DATEX OHMEDA AESTIVA 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *