BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADU CARESTATION

    MDR report key: 1883558 · Received September 27, 2010

    Report

    Report Number
    1883558
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    June 3, 2010
    Report Date
    September 27, 2010
    Manufacturer
    DATEX-OHMEDA INC DIV GE HEALTHCARE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIA MACHINE SYSTEM CHECK-OUT PROCEDURE WAS PASSED IN AM PRIOR TO START OF THE DAY'S CASES. DURING THE FIRST CASE, THE VENTILATOR TURNED ON, BUT THE CRNA CERTIFIED REGISTERED NURSE ANESTHETIST NOTICED THAT BELLOWS WERE NOT CYCLING. THE CASE PROCEEDED WITH MANUAL VENTILATION AND THE MACHINE WAS CHANGED-OUT AFTER THE CASE. THE PATIENT SUFFERED NO ADVERSE EFFECTS.======================MANUFACTURER RESPONSE FOR ANESTHESIA UNIT, DATEX-OHMEDA ADU======================RECOMMEND THE ON-SITE BIOMED TECH TO CHECK DIAGNOSTICS FOR BOTH FGCFRESH GAS CONTROL AND VENT. MONITOR DIGIPOWER VOLTAGES AND INSPECT PROPORTIONAL VALVE. IF NO PROBLEMS FOUND, DO FUNCTIONAL CHECK AND RETURN TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADU CARESTATION GAS-MACHINE, ANESTHESIA BSZ DATEX-OHMEDA INC DIV GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR