BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3041833 · Received April 8, 2013

    Report

    Report Number
    9611451-2013-00243
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) OF THE SIMILAR PRODUCT IS K983112. METHOD: THE COMPLAINT ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE DRYLINE TUBE SUSTAINED A HOLE, ABOUT 15.5CM AWAY FROM THE CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120120. CONCLUSION: IT WAS IDENTIFIED THAT DAMAGE TO THE RT206 DRYLINES WAS CAUSED BY A FAULTY CORRUGATOR BLOCK THAT WAS USED DURING THE DRYLINE MANUFACTURING PROCESS. THE FAULTY BLOCK WAS REPLACED LAST YEAR. THE COMPLAINT DRYLINE TUBE WA MANUFACTURED PRIOR TO THE REPLACEMENT OF THE FAULTY CORRUGATOR BLOCK. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY (B)(4) AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS FOR THE RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "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 A DISTRIBUTOR THAT AN RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DUE TO A PINHOLE ON THE DRYLINE TUBE. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143022 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT206 120120

    Patients

    Seq Age Sex Outcome Treatment
    1