BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2703250 · Received August 16, 2012

    Report

    Report Number
    9611451-2012-00559
    Event Type
    Malfunction
    Date Received
    August 16, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 27, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 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: ONLY THE DRYLINE TUBE OF THE COMPLAINT DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR VISUAL INSPECTION. RESULTS: VISUAL INSPECTION REVEALED THAT A HOLE WAS FOUND APPROXIMATELY 2 CM AWAY FROM THE CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 120126. CONCLUSION: IT WAS IDENTIFIED THAT HOLE DAMAGE TO THE DRYLINE TUBE COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS, ALTHOUGH IT IS NOT A BATCH RELATED ISSUE. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 MINUTES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT206 BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT206 ADULT BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST AND A PINHOLE WAS FOUND ON THE DRYLINE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206 120126

    Patients

    Seq Age Sex Outcome Treatment
    1