BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1692459 · Received May 12, 2010

    Report

    Report Number
    9611451-2010-00278
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 13, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT212 BREATHING CIRCUIT WAS NOT RETURNED TO US FOR EVALUATION. RESULTS: A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090814. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS POSSIBLE THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED CIRCUIT. THERE ARE STANDARD OPERATING PROCEDURES (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. OMITTING TO PACK THE MOST SIGNIFICANT COMPONENT IN THE BREATHING CIRCUIT KIT IS AN UNLIKELY EVENT AND THIS IS THE ONLY COMPLAINT OF THIS TYPE THAT WE HAVE RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED THAT THE INSPIRATORY CIRCUIT WAS NOT INCLUDED WITH AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT KIT. THIS WAS FOUND BEFORE USE ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT212 090814

    Patients

    Seq Age Sex Outcome Treatment
    1