BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL, INC.

    MDR report key: 2536623 · Received April 10, 2012

    Report

    Report Number
    MW5025022
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    February 22, 2012
    Report Date
    April 10, 2012
    Manufacturer
    HAMILTON MEDICAL, CIN.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS AT PT BESIDE WHEN VENTILATOR DISPLAYED ¿CHECK FLO SENSOR¿ ALARM. VENTILATOR WENT INTO SAFETY MODE AND CEASED VENTILATING THE PT. THE RESPIRATOR THERAPIST WAS CALLED IMMEDIATELY AND THE PT WAS MANUALLY VENTILATED ON 100 % OXYGEN. PT BEGAN TO SPONTANEOUSLY BREATH ON HER OWN. RESPIRATORY THERAPIST ARRIVED AND SWITCHED OUT THE VENTILATOR. NO NEGATIVE CLINICAL OUTCOME RELATED TO THIS EVENT FOR THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| S