BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1247015 · Received November 27, 2008

    Report

    Report Number
    9611451-2008-00696
    Event Type
    Malfunction
    Date Received
    November 27, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE LOT DATES INVOLVED IN THIS COMPLAINT WERE: 080910, 080924 AND 081016. THE DEVICE MFR DATES WERE: 9/10/08, 9/08/24 AND 10/16/08. WE ARE CURRENTLY INVESTIGATING THE RETURNED BREATHING CIRCUITS. LOT CHECKS REVEALED NO OTHER SIMILAR COMPLAINTS FOR THESE LOT NUMBERS. WE WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT THE VENTILATOR ISSUED A LEAKAGE ALARM WHILE USING AN RT340 ADULT BREATHING CIRCUIT. THE HOSPITAL REPORTED THEY FOUND A HOLE ON THE CONNECTOR THAT CONNECTS TO THE Y PIECE. WHEN THE HOLE WAS COVERED, THE VENTILATOR STOPPED ALARMING AND THE LEAKAGE WAS STOPPED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD. RT340

    Patients

    Seq Age Sex Outcome Treatment
    1