BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1202145 · Received October 16, 2008

    Report

    Report Number
    9611451-2008-00611
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 9, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    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 REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. METHOD: ELECTRICAL TESTS WERE PERFORMED ON THE RETURNED BREATHING CIRCUIT. RESULTS: THE HEATERWIRE IN THE INSPIRATORY TUBE OF THE BREATHING CIRCUIT WAS AN ELECTRICAL OPEN CIRCUIT. WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFORMATION WAS PROVIDED WITH THIS COMPLAINT. CONCLUSIONS: 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. CHANGES HAVE BEEN MADE TO THE CRIMPING PROCESS WITH THE REPLACEMENT OF ALL CRIMPING MACHINES ON THE PRODUCTION LINE IN NOVEMBER 2007. AS NO LOT INFORMATION WAS PROVIDED, WE WERE UNABLE TO ASCERTAIN WHETHER THE PRODUCT IN THIS COMPLAINT WAS MANUFACTURED BEFORE OR AFTER THE EFFECTIVE DATE OF THIS CHANGE. (B) (4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B) (6) REPORTED VIA OUR DISTRIBUTOR THAT SHORTLY AFTER STAFF STARTED USING AN RT106 ADULT BREATHING CIRCUIT, THE HEATERWIRE ALARM WENT OFF. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT106

    Patients

    Seq Age Sex Outcome Treatment
    1