BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1220357 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00648
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN BOTH THE INSPIRATORY AND EXPIRATORY TUBES OF THE RT340 BREATHING CIRCUITS WAS TESTED USING A MULTIMETER. RESULTS: THE INSPIRATORY HEATER WIRE IN THE CIRCUIT WAS AN OPEN LOOP DUE TO A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE PINS THAT CRIMPS TO THE HEATER WIRE. NO LOT CHECK COULD BE PERFORMED AS NO LOT NUMBER HAS BEEN PROVIDED. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME AN OPEN CIRCUIT POST CONNECTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. FURTHER DESIGN IMPROVEMENTS TO THE EXISTING CRIMPING MACHINES ARE IN PROGRESS. OUR MONITORING AND TRENDING OF OPEN CIRCUIT HEATER WIRES IN ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE IN THE LAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE HEATER WIRE WAS NOT FUNCTIONING IN AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. REPLACING THE BREATHING CIRCUIT RESOLVED THE PROBLEM. THIS WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT340

    Patients

    Seq Age Sex Outcome Treatment
    1