BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL, INC.

    MDR report key: 2536476 · Received April 10, 2012

    Report

    Report Number
    MW5025006
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    March 4, 2012
    Report Date
    April 10, 2012
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON A HAMILTON MODEL C-2 VENTILATOR. THE VENTILATOR DISPLAYED A 'VENTILATOR MALFUNCTION' MESSAGE AND CEASED PROVIDING VENTILATION TO THE PATIENT. THE PATIENT WAS IMMEDIATELY MANUALLY VENTILATED UNTIL SUCH TIME AS A REPLACEMENT VENTILATOR COULD BE SET UP. NO HARM OCCURRED TO THE PATIENT. PER THE MANUFACTURER, IT IS BELIEVED THAT THE ALARM MESSAGE IS TRIGGERED WHEN THE C2'S PRESSURE MONITORING AND PRESSURE DELIVERY SENSORS DETECT A MISMATCH IN SIGNALS AND DIRECT THE VENTILATOR TO ENTER AMBIENT MODE. IN THIS CASE THERE IS NO FAILURE OF THE SENSORS, BUT A FALSE POSITIVE ACTIVATION OF THE ALARM MESSAGE CAUSED BY OSCILLATIONS IN THE PATIENT CIRCUIT. THESE OSCILLATIONS OCCUR AT 100 HZ WHICH CORRESPONDS WITH THE SAMPLING RATE OF THE C-2 SENSORS. THE MANUFACTURER REPORTS THAT THEY CANNOT REMOVE THE PRESSURE MONITORING PROCESS AS IT IS PART OF THEIR SAFETY MEASURING PROCESS. THEY ALSO REPORT THAT CHANGING THE SAMPLING RATE WILL NOT NECESSARILY FIX THE PROBLEM BECAUSE OSCILLATIONS OCCUR AT OTHER FREQUENCIES RESULTING IN THE SAME TYPE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON MEDICAL, INC. HAMILTON MEDICAL, INC C-2 VENTILATOR CBK C-2

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| S