BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2028935 · Received March 24, 2011

    Report

    Report Number
    9611451-2011-00194
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION.WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE EXPIRATORY LIMB OF THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE FOR TESTING. THE BREATHING CIRCUIT LIMB WAS TESTED FOR BENT OR BROKEN HEATER WIRE PINS. RESULTS: ONE OF THE INSPIRATORY HEATER WIRE PINS WAS BENT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091014. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO DAMAGE THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR DAMAGED PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED DURING PRODUCTION OR BY THE END USER. DAMAGED PINS DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. OUR TRENDING FOR BENT OR BROKEN HEATER WIRE PINS ON ADULT BREATHING CIRCUITS HAS A RATE WORLDWIDE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE IN AN RT235 BREATHING CIRCUIT WAS FAULTY.THE FAULT WAS FOUND DURING PRE-USE TESTING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE IN AN RT235 BREATHING CIRCUIT WAS FAULTY. THE FAULT WAS FOUND DURING PRE-USE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT235 091014

    Patients

    Seq Age Sex Outcome Treatment
    1