BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1060007 · Received June 11, 2008

    Report

    Report Number
    9611451-2008-00179
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Report Date
    March 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT RETURNED TO THE MFR. AN INVESTIGATION WAS CONDUCTED BASED ON THE EVENT INFO PROVIDED BY A STAFF REP FOLLOWING A VISIT TO THE SITE. RESULT: WHEN THE REP VISITED THE HOSP THEY IDENTIFIED THE PRESSURE LINE WAS BEING CONNECTED TO THE WRONG PORT. CONCLUSION: THERE ARE THREE PORTS ON THE Y PIECE OF THE BREATHING CIRCUIT SPECIFIC FOR A PRESSURE LINE, A PROBE CONNECTION AND FOR A MEASURED DOSE INHALER. EACH OF THESE THREE PORTS IS SIZED DIFFERENTLY FOR EACH SPECIFIC PORT CONNECTION. POOR CONNECTION WILL CAUSE GAS LEAKAGE. IN THIS CASE THE USER CONNECTED THE PRESSURE LINE TO THE INCORRECT PORT. A REP FROM THE AREA CONDUCTED TRAINING WITH THE USERS ON THE CORRECTION CONNECTION OF THE BREATHING CIRCUIT.

    Description of Event or Problem · 1

    A HOSP IN ANOTHER COUNTRY REPORTED TO OUR DISTRIBUTOR THAT THE VENTILATOR (BABYLOG DRAGER) COULD NOT MAINTAIN PRESSURE WITH THE RT235 INFANT BREATHING CIRCUIT ATTACHED. IT WAS REPORTED THAT THERE WAS A LEAK IN THE PRESSURE LINE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT235 080212

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAGER BABLOG VENTILATOR