BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100A HFOV

    MDR report key: 1883836 · Received September 20, 2010

    Report

    Report Number
    1883836
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    June 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    CAREFUSION VIASYS HEALTHCARE
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    NO CHEST WIGGLE FROM VENT. VENTILATOR HAD STOPPED WORKING & THERE WAS NO AUDIBLE ALARM. VENTILATOR WAS REPLACED WITH A FUNCTIONING HFOV.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NO ADVERSE EVENT. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3100A HFOV VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION VIASYS HEALTHCARE * *
    2 3100A HFOV VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION VIASYS HEALTHCARE 3100A HFOV *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA