BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT UNHEATED BREATHING CIRCUIT

    MDR report key: 2655571 · Received July 16, 2012

    Report

    Report Number
    9611451-2012-00459
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    June 18, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ELBOW ASSEMBLY OF THE RT134 INSPIRATORY TUBE CONSISTS OF AN ELBOW AND A SEALING CAP. AN ASSEMBLY JIG IS USED TO CORRECTLY INSERT THE SEALING CAP INTO THE ELBOW. METHOD: THE RETURNED RT134 ADULT UNHEATED BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR VISUAL INSPECTION. RESULTS: VISUAL INSPECTION REVEALED THAT THE SEALING CAP WAS PUSHED TOO FAR INTO THE ELBOW, WHICH RESULTED TO THE REPORTED "GAP" AND, CONSEQUENTLY, LED TO BREATHING CIRCUIT LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 111015. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAULT OBSERVED. ALL ADULT BREATHING CIRCUITS, TOGETHER WITH THE ELBOW ASSEMBLIES, ARE PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT134 ADULT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THE ELBOW ASSEMBLY WAS DAMAGED POST PRODUCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT134 ADULT UNHEATED BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE INSPIRATORY LIMB OF AN RT134 ADULT UNHEATED BREATHING CIRCUIT WAS LEAKING DUE TO THE "OBVIOUS GAP" ON THE ADAPTOR. THIS WAS NOTICED BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE INSPIRATORY LIMB OF AN RT134 ADULT UNHEATED BREATHING CIRCUIT WAS LEAKING DUE TO THE "OBVIOUS GAP" ON THE ADAPTOR. THIS WAS NOTICED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT UNHEATED BREATHING CIRCUIT BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED RT134 111015

    Patients

    Seq Age Sex Outcome Treatment
    1