BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 2122554 · Received June 14, 2011

    Report

    Report Number
    9611451-2011-00354
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS VISUALLY INSPECTED AND TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE. VISUAL INSPECTION REVEALED THAT THE INSPIRATORY HEATER WIRE PIN WAS BENT. THIS PREVENTED THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET DURING SETUP OF THE BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 100708. CONCLUSION: IT IS POSSIBLE FOR THE USER TO BEND THE HEATER WIRE PINS IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT329 100708

    Patients

    Seq Age Sex Outcome Treatment
    1