BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2795502 · Received October 18, 2012

    Report

    Report Number
    9611451-2012-00739
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 20, 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 CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND THE HEATER WIRE RESISTANCE WAS MEASURED WITH A CALIBRATED MULTIMETER. RESULTS: VISUAL INSPECTION REVEALED THE SECRETION WAS IN A BROWN-LIKE COLOR AND THE INSPIRATORY LIMB WAS NOT BURNT. NO DAMAGE WAS OBSERVED ON THE INSPIRATORY LIMB OF THE COMPLAINT DEVICE. THE HEATERWIRE RESISTANCE MEASURED WAS WITHIN SPECIFICATION. CONCLUSION: OUR INVESTIGATION CONCLUDED THAT NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT DEVICE. PATIENT SECRETION FOUND IN THE BREATHING CIRCUIT IS NORMAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE SECRETION IN THE INSPIRATORY LIMB OF AN RT125 INFANT BREATHING CIRCUIT WAS BURNT AFTER ONE WEEK OF 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