BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 3250776 · Received May 2, 2013

    Report

    Report Number
    3250776
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CAREFUSION 207, INC DBA CAREFUSION
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CIRCUIT ON THE HIGH FREQUENCY VENTILATOR FAILED CALIBRATION TEST DUE TO "BAD DIAPHRAGM ON CIRCUIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193797 VIASYS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 207, INC DBA CAREFUSION 3100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *