BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON GALILEO

    MDR report key: 222847 · Received May 10, 1999

    Report

    Report Number
    MW1016277
    Event Type
    Injury
    Date Received
    May 10, 1999
    Date of Event
    May 7, 1999
    Report Date
    May 10, 1999
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    A MONITOR TECH RESPONDED TO A LOW OXYGEN SATURATION ALARM OF 54%. THE VENTILATOR CIRCUIT WAS FOUND DISCONNECTED FROM THE PT AND THE PT WAS CYANOTIC AND GASPING. THE PT WAS MANUALLY VENTILATED WITH 100% OXYGEN, AND ONCE COLOR IMPROVED WAS PLACED BACK ON THE VENTILATOR. THE VENTILATOR ALARMED DISCONNECT, HOWEVER NURSING PERSONNEL DID NOT SENSE THE URGENCY OF THE VENTILATOR ALARM. THE VENTILATOR BEEPED FIVE TIMES, PAUSED FOR 5 SECS, AND BEEPED AGAIN FIVE TIMES FOLLOWED BY THE PAUSE. OTHER VENTILATORS AT THIS INSTITUTION ALARM A CONTINUOUS TONE WITHOUT INTERRUPTION WHEN THERE IS A DISCONNECT. NURSING HAS BEEN EDUCATED ABOUT THE ALARM SYSTEM, BUT STILL FEEL THE ALARM IS NOT LOUD ENOUGH TO OBTAIN ATTENTION, AND SHOULD BE A CONTINUOUS TONE TO ALERT THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening