BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADU CARESTATION

    MDR report key: 1883512 · Received October 11, 2010

    Report

    Report Number
    1883512
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 11, 2010
    Manufacturer
    DATEX-OHMEDA, DIVISION OF GE HEALTHCARE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA DELIVERY UNIT STOPPED VENTILATING PATIENT, CRNA CERTIFIED REGISTERED NURSE ANETHESTHETIST AND SRNA STUDENT REGISTERED NURSE ANESTHETIST HAD TO HAND VENTILATE UNTIL NEW MACHINE COULD BE BROUGHT INTO ROOM. CRNA BOARD RUNNER LOCATED ANOTHER MACHINE AND BROUGHT INTO ROOM. PATIENT REMAINED HEMODYNAMICALLY STABLE AND AMNESTIC THROUGHOUT THE CHANGE IN ANESTHESIA MACHINE. VENTILATOR THOUGHT TO HAVE FAILED WHILE CHANGING BETWEEN PRESSURE CONTROL VENTILATION AND VOLUME CONTROL. BIOMED REVIEWED ERROR CODES ON MACHINE. CONTACTED MANUFACTURER AND DETERMINED THAT THE INSPIRATIONAL PROPORTIONAL VALVE NEEDS TO BE REPLACED. WILL REPAIR AND RETURN TO SERVICE.======================HEALTH PROFESSIONAL'S IMPRESSION======================ADU MALFUNCTIONED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADU CARESTATION ANESTHESIA DELIVERY UNIT BSZ DATEX-OHMEDA, DIVISION OF GE HEALTHCARE S/5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR