BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3020033 · Received March 25, 2013

    Report

    Report Number
    9611451-2013-00213
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 27, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY AND THE EXPIRATORY TUBES OF THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE TUBES WERE VISUALLY INSPECTED AND ELECTRICAL RESISTANCE TESTED USING A MULTIMETER. A CONTINUITY TEST WAS ALSO CONDUCTED TO LOCATE THE BREAK IN THE HEATER WIRES. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED WITH THE RETURNED TUBES. ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT. CONTINUITY TESTING REVEALED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATER WIRE WAS LOCATED IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE RIGHT HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG. NO FAULT WAS FOUND WITH THE EXPIRATORY HEATER WIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120912. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A LOW TEMPERATURE ALARM SOUNDED ON THE HUMIDIFIER WHILE AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS BEING USED ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED. IT WAS FURTHER REPORTED THAT THE ALARM STOPPED WHEN THE NEW RT340 BREATHING CIRCUIT WAS CONNECTED TO THE HUMIDIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122499 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120912

    Patients

    Seq Age Sex Outcome Treatment
    1