BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1063642 · Received June 19, 2008

    Report

    Report Number
    9611451-2008-00373
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 19, 2008
    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 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 RETURNED DEVICE WAS ELECTRICALLY TESTED. RESULTS: THE HEATERWIRE IN THE INSPIRATORY TUBE WAS AN ELECTRICAL OPEN CIRCUIT. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATERWIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATERWIRE BECAME AN OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B) (4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED VIA OUR DISTRIBUTOR THAT ONE OF THE HEATERWIRE OF AN RT105 ADULT BREATHING CIRCUIT WAS AN OPEN CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT105 080229

    Patients

    Seq Age Sex Outcome Treatment
    1