BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON VEOLAR VENTILATOR

    MDR report key: 34301 · Received June 12, 1996

    Report

    Report Number
    34301
    Event Type
    Death
    Date Received
    June 12, 1996
    Date of Event
    May 29, 1996
    Report Date
    June 10, 1996
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH A DIAGNOSIS OF PNEUMONIA/ARDS. ON VENTILATOR FOR 3 WEEKS WITH A TRACHEOSTOMY. SIX OTHER VENTILATORS IN USE IN ICU AT THE TIME. PT BECAME DISCONNECTED FROM VENT. STAFF WERE UNABLE TO HEAR VENTILATOR ALARMS AND RESPONDED ONLY WHEN THE CARDIAC MONITOR BRADYCARDIA ALARM SOUNDED. UNABLE TO RESUSCITATE PT. 13 BED ICU UNIT IS LARGE. ADJUSTABLE ALARM VOLUME CONTROL WAS ON LOWEST SETTING. MACHINE DID NOT MALFUNCTION. ALARM VOLUMES WERE CHECKED WITH MFR SPECS USING A DECIBEL METER: LOW-66DBA, HIGH-72 DBA. MACHINE WAS TESTED IN SAME ROOM. ON LOW VOLUME SETTING, ALARM WAS DIFFICULT TO HEAR IN NURSE'S STATION. ALARM TONE SEEMS TO BLEND IN WITH BACKGROUND NOISES, OTHER ALARMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death