BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2800766 · Received October 22, 2012

    Report

    Report Number
    9611451-2012-00742
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT106 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 10CM AWAY FROM THE CONNECTOR OF THE DRYLINE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS PRODUCT. CONCLUSION: IT WAS IDENTIFIED THAT THE DAMAGE TO THE RT106 DRYLINE WAS CAUSED BY A FAULTY CORRUGATOR BLOCK THAT WAS USED DURING THE DRYLINE MANUFACTURING PROCESS. THE FAULTY BLOCK WAS REPLACED IN (B)(4) 2012. WE HAVE NOT RECEIVED ANY COMPLAINTS OF THIS NATURE FOR PRODUCT MANUFACTURED AFTER (B)(4) 2012. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 TO 15 MINUTES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT106 ADULT INSPIRATORY-HEATED 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 THAT THE RT106 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT DID NOT PASS THE EVITA VENTILATOR LEAK TEST PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT106 120210

    Patients

    Seq Age Sex Outcome Treatment
    1 EVITA VENTILATOR