BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1610122 · Received February 8, 2010

    Report

    Report Number
    9611451-2010-00055
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 8, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS FAMILIAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE RETURNED RT225 INFANT BREATHING CIRCUIT WAS PRESSURE TESTED USING A MULTIMETER. RESULTS: THIS BREATHING CIRCUIT WAS FOUND TO BE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: NO FAULT WAS FOUND WITH THIS CIRCUIT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA THEIR DISTRIBUTOR THAT AN RT225 INFANT BREATHING CIRCUIT FAILED A LEAK TEST. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225 090529

    Patients

    Seq Age Sex Outcome Treatment
    1