BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1590465 · Received January 27, 2010

    Report

    Report Number
    9611451-2010-00036
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 18, 2009
    Report Date
    December 18, 2009
    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 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 RETURNED RT125 BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR SIGNS OF DISCOLORATION, AS REPORTED. RESULTS: DISCOLORATION WAS OBSERVED IN THE INSPIRATORY TUBE OF THE BREATHING CIRCUIT. CONCLUSION: THE DISCOLORATION IN THE BREATHING CIRCUIT IS NORMAL PT SECRETIONS.

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE INSIDE OF A RT125 INFANT BIAS FLOW BREATHING CIRCUIT CHANGED COLOR DURING USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1