BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-G5

    MDR report key: 2019677 · Received March 11, 2011

    Report

    Report Number
    2937708-2011-00001
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    December 30, 2010
    Report Date
    March 11, 2011
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE COMPLAINT HAS SHOWN THAT THE ADAPTIVE VOLUME/PRESSURE REGULATION OF THE HAMILTON-G5 WITH NEONATAL OPTION CAN BE AUTOMATICALLY AND CONTINUOUSLY REDUCED TO PEEP + 3 MBAR WHEN A CLOSED SUCTIONING MANEUVER IS PERFORMED ON THE PT, AND THAT THIS CONDITION MAY BE UNDETECTED BY THE OPERATOR (ALARMING BY THE INSTRUMENT NOT ENSURED IN ALL CASES). THIS MAY LEAD TO HYPOXIA OF THE PT. THE ABOVE DESCRIBED SITUATION CAN ONLY OCCUR WHEN THE HAMILTON-G5 IS OPERATED WITH THE SOFTWARE V2.01X, WITH THE NEONATAL OPTION, AND WITH THE ADAPTIVE VOLUME/PRESSURE VENTILATION MODES APV-SIMV/APV-CMV. IN ALL OTHER PT SETTINGS (PEDIATRIC, ADULT) AND IN ALL OTHER VENTILATION MODES, THE VENTILATION IS CONTINUED AFTER A CLOSED SUCTIONING MANEUVER ON THE PT, OR THE OPERATOR IS ALARMED ABOUT A POSSIBLE PROBLEM. THE ROOT CAUSE IS A DESIGN ERROR OF AN ALARM ROUTINE IN THE NEONATAL OPTION IN THE SOFTWARE V2.01X. A "MEDICAL DEVICE SAFETY ALERT AND CORRECTIVE ACTION" INFO WILL BE DISTRIBUTED TO THE OPERATORS OF ALL AFFECTED HAMILTON-G5 VENTILATORS WITH NEONATAL OPTION. THE OPERATOR SHALL DEACTIVATE THE VTHIGH ALARM IN THE CONFIGURATION MENU AS DESCRIBED IN THE OPERATOR'S MANUAL UNTIL THE VENTILATOR IS UPGRADED WITH CORRECTED SOFTWARE. REVISED SOFTWARE WILL BE DEVELOPED AND TESTED TO SOLVE THE DESIGN FLAW. ALL AFFECTED HAMILTON G-5 INSTRUMENTS WITH SOFTWARE V2.01X WITH NEONATAL OPTION WILL BE UPGRADED.

    Description of Event or Problem · 1

    NEONATAL PATIENT WAS VENTILATED WITH THE APV-SIMV MODE AND A CLOSED SUCTIONING MANEUVER WAS PERFORMED. PT WAS NOT VENTILATED FOR 43 SECONDS AFTER THE SUCTIONING MANEUVER. VENTILATOR DID NOT ALARM. INSTRUMENT WAS DISCONNECTED AND PT MANUALLY VENTILATED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON-G5 VENTILATOR, CONTINUOUS CBK HAMILTON MEDICAL AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention