BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAQUA RT235

    MDR report key: 1081674 · Received July 10, 2008

    Report

    Report Number
    1081674
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 10, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR CIRCUIT (FISHER & PAYKEL RT235) PATIENT WYE WILL SNAP-OFF AND CAUSE A SIGNIFICANT AIR LEAK WITH A DROP IN VENTILATOR PRESSURE.====================== MANUFACTURER RESPONSE FOR VENTILATOR CIRCUIT, EVAQUA RT235======================SPOKE WITH COMPANY REP AND HE SAID THEY ARE AWARE OF THE PROBLEM AND WOULD WORK TO CORRECT THE PROBLEM. ALSO, WOULD SEND A CASE OF CIRCUITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAQUA RT235 BREATHING CIRCUIT, INFANT BZO FISHER & PAYKEL HEALTHCARE, LTD. RT235 080326

    Patients

    Seq Age Sex Outcome Treatment
    1 *