BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2893838 · Received January 2, 2013

    Report

    Report Number
    9611451-2013-00004
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 6, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A HOLE ON THE DRYLINE APPROXIMATELY 15.5 CM AWAY FROM THE CONNECTOR. CONCLUSION: IT WAS IDENTIFIED THAT THE DAMAGE TO THE RT134 DRYLINE COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS. 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. OUR USER INSTUCTIONS THAT ACCOMPANY THIS DEVICE STATES 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT134 BREATHING CIRCUIT IS IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT134 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON THE VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT134 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON THE VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT134 120210

    Patients

    Seq Age Sex Outcome Treatment
    1