BEUDAMED
    FDA Adverse Event Summary report: N

    HAMILTON-G5

    MDR report key: 3590709 · Received December 16, 2013

    Report

    Report Number
    3590709
    Date Received
    December 16, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RED ALARM WHILE ON PATIENT NO VENTILATION, TOUCHSCREEN NOT WORKING, AND ALARM SILENCE/O2 NOT FUNCTIONING. INTERNAL BATTERY AND AC LIGHTS BOTH HAD A X THRU THEM.====================== MANUFACTURER RESPONSE FOR VENTILATOR, G5 (PER SITE REPORTER).======================TO SEND THEM THE EVENT LOGS FOR REVIEW AND THEY WILL GET BACK TO ME WITH THE FINAL CONCLUSION.EVENT LOGS: GCP TF: TF : 5500 -> TF_ALRM_GCP_TF_SERVO_SUPPLY : 1.TF : 5501 -> TF_ALRM_GCP_TF_SENSOR_SUPPLY : 1.TF : 5502 -> TF_ALRM_GCP_TF_ADC_15V_SUPPLY : 1.TF : 5503 -> TF_ALRM_GCP_TF_AD_CONVERTER : 1.TF : 5505 -> TF_ALRM_GCP_TF_P_TANK_HIGH : 1.TF : 5506 -> TF_ALRM_GCP_TF_P_TANK_HIGH_HW : 1.TF : 5507 -> TF_ALRM_GCP_TF_MIXER_VALVE_OPEN : 1.TF : 5509 -> TF_ALRM_GCP_TF_SERVO_OUTPUT : 1.TF : 5514 -> TF_ALRM_GCP_TF_BUZZER : 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657524 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL, INC. 159001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *