BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1586028 · Received January 21, 2010

    Report

    Report Number
    9611451-2010-00032
    Event Type
    Malfunction
    Date Received
    January 21, 2010
    Date of Event
    November 27, 2009
    Report Date
    November 27, 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 BREATHING CIRCUIT WAS INSPECTED FOR MISSING COMPONENTS. RESULTS: INSPECTION OF THE COMPLAINT DEVICE CONFIRMED THAT A LABEL WAS MISSING FROM THE BREATHING CIRCUIT PACKAGING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED TAG. THERE ARE STANDARD OPERATING PROCEDURE (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. NO PT CONSEQUENCE OCCURRED AS A RESULT OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THEY RECEIVED AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT WITHOUT A LABEL. THE MISSING LABEL WAS OBSERVED BEFORE PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT125 090914

    Patients

    Seq Age Sex Outcome Treatment
    1