BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2736506 · Received September 9, 2012

    Report

    Report Number
    9611451-2012-00607
    Event Type
    Malfunction
    Date Received
    September 9, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT125 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K20332. METHOD: THE COMPLAINT RT125 BREATHING CIRCUITS ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AS THEY HAVE BEEN DISCARDED BY THE HOSPITAL. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE HOSPITAL REPORTED THAT TWO RT125 BREATHING CIRCUITS BECAME OPEN CIRCUIT AFTER 3 DAYS OF USE. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE OPEN CIRCUIT WOULD MOST LIKELY OCCUR IN THE HEATERWIRE PATH OF THE INSPIRATORY LIMB OF THE BREATHING CIRCUIT. WITHOUT A COMPLAINT DEVICE, IT IS NOT POSSIBLE TO ACCURATELY CONCLUDE THE ROOT CAUSE OF THE OPEN CIRCUIT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT125 INFANT BREATHING CIRCUITS BECAME OPEN CIRCUIT THREE DAYS AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT125

    Patients

    Seq Age Sex Outcome Treatment
    1