BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 3150786 · Received June 6, 2013

    Report

    Report Number
    9611451-2013-00454
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT329 CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WERE THUS UNABLE TO CONFIRM THE REPORTED FAULT OR DETERMINE THE CAUSE OF THE REPORTED FAULT. WE SOUGHT INFORMATION FROM THE HOSPITAL TO DETERMINE WHETHER THE TEMPERATURE PROBE AND THE RT329 CIRCUIT WERE SET UP CORRECTLY, BUT NO INFORMATION WAS SUPPLIED. IF THE TEMPERATURE PROBE WAS NOT INSERTED CORRECTLY AS PER THE USER INSTRUCTIONS THEN INCORRECT SET UP IS MOST LIKELY THE REASON FOR THE DISCONNECTION OF THE TEMPERATURE PROBE FROM THE RT329 CIRCUIT. A DISCONNECTED TEMPERATURE PROBE WOULD HAVE CAUSED LEAK AND THE LOSS OF LOW DESCRIBED BY THE CUSTOMER. UNDER CORRECT SETUP, THE TEMPERATURE PROBE AND THE RT329 CIRCUIT COMPLY WITH (B)(4), SECTION DD.2: "TEST METHOD FOR SECURITY OF ENGAGEMENT OF TEMPERATURE SENSORS TO MATING PORTS." THE USER INSTRUCTIONS THAT ACCOMPANY THE RT329 CIRCUIT CONTAIN A PICTORIAL DIAGRAM THAT SHOWS HOW TO CONNECT THE TEMPERATURE PROBE TO THE RT329 CIRCUIT CORRECTLY. THE USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE"; "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."; "PATIENT MONITORING IS RECOMMENDED."; "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN NEW (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE PROXIMAL TEMPERATURE PROBE KEPT "POPPING OFF" AN RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT LEADING TO REDUCTION OF FLOW TO THE PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250248 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT329

    Patients

    Seq Age Sex Outcome Treatment
    1