BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT EVAQUA BREATHING CIRCUIT

    MDR report key: 1172312 · Received September 19, 2008

    Report

    Report Number
    9611451-2008-00544
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    August 25, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). METHOD: ONLY 1 OF THE 3 RT235 BREATHING CIRCUITS WAS RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. THE RETURNED DEVICE WAS NOT A WHOLE CIRCUIT BUT HAD BEEN CUT OFF AT ONE END. AN ATTEMPT WAS MADE TO INSERT A HEATER WIRE ADAPTER TO THE HEATER WIRE SOCKET OF THE INSPIRATORY TUBE. RESULTS: THE HEATED BREATHING CIRCUIT CONTAINS A HEATER WIRE SOCKET FOR CONNECTION TO THE HUMIDIFIER. IN THIS CASE, THE HEATER WIRE ADAPTER COULD NOT BE INSERTED AS ONE OF THE HEATER WIRE PINS WAS BENT. UPON FURTHER INSPECTION, THE TIP OF THE PIN WAS DISCOVERED TO BE SLIGHTLY CRUSHED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: FISHER & PAYKEL HEALTHCARE IMPLEMENTED IMPROVEMENTS TO THE PRODUCTION PROCESS IN RESPECT OF INFANT BREATHING CIRCUITS IN MAY 2007 WITH THE AIM OF PREVENTING BENT PINS FROM PASSING THE PRODUCTION TEST. THIS IS ACHIEVED THROUGH PRIOR IDENTIFICATION AND REJECTION OF DAMAGED HEATER WIRE PINS. THIS EVENT OCCURRED ON A DEVICE AFTER THE PRODUCTION IMPROVEMENTS. IT IS POSSIBLE THAT A DAMAGED PIN, WHILST PASSING THE FINAL ELECTRICAL RESISTANCE PRODUCTION TEST, CAN BE FURTHER DAMAGED DURING SET-UP AND CONNECTION OF THE EQUIPMENT WHEN USED. (B) (4).

    Description of Event or Problem · 1

    OUR DISTRIBUTOR IN (B) (6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE ELECTRICAL HEATER WIRE SOCKET IN THE RT235 INFANT EVAQUA BREATHING CIRCUIT COULD NOT BE CONNECTED TO THE HUMIDIFIER. THIS WAS OBSERVED IN 3 DEVICES. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT235 080514

    Patients

    Seq Age Sex Outcome Treatment
    1