BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HEATED BREATHING CIRCUIT

    MDR report key: 3318251 · Received August 29, 2013

    Report

    Report Number
    9611451-2013-00649
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K100554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT241 ADULT HEATED BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND THE HEATER WIRE WAS TESTED FOR CONTINUITY. RESULTS: THE HEATER WIRE ON THE RETURNED BREATHING CIRCUIT DID NOT PASS THE CONTINUITY TEST AND WAS FOUND TO BE OPEN CIRCUIT. VISUAL INSPECTION REVEALED NO DAMAGE TO THE RETURNED BREATHING CIRCUIT A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130304. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATERWIRE DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT241 BREATHING CIRCUITS ARE RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE COMPLAINT DEVICE WAS WITHIN SPECIFICATION PRIOR TO BEING RELEASED FOR DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT241 ADULT BREATHING CIRCUITED CAUSED AN ALARM ON A MR880 HUMIDIFIER. THE ALARM WAS RESOLVED AFTER THE BREATHING CIRCUIT WAS CHANGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428107 ADULT HEATED BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT241 130304

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR880 RESP. HUMIDIFIER