BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2844181 · Received November 25, 2012

    Report

    Report Number
    9611451-2012-00846
    Event Type
    Malfunction
    Date Received
    November 25, 2012
    Report Date
    November 1, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 COMPLAINT RT206 DRYLINE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE TUBING WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS A HOLE IN THE DRYLINE, ABOUT 16CM AWAY FROM THE CONNECTOR. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: IT WAS IDENTIFIED THAT THE DAMAGE TO THE DRYLINE TUBE WAS CAUSED BY A FAULTY CORRUGATOR BLOCK THAT WAS USED DURING THE DRYLINE MANUFACTURING PROCESS. THE FAULTY BLOCK WAS REPLACED IN (B)(6) 2012. WE HAVE NOT RECEIVED ANY COMPLAINTS OF THIS NATURE FOR PRODUCT MANUFACTURED AFTER (B)(6) 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 RT105 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 DISTRIBUTOR IN (B)(6) REPORTED THAT THE DRYLINE OF AN RT206 ADULT BREATHING CIRCUIT HAD A HOLE IN IT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1