BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1182679 · Received September 25, 2008

    Report

    Report Number
    9611451-2008-00548
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    August 29, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN BOTH INSPIRATORY AND EXPIRATORY TUBES OF THE RT200 BREATHING CIRCUIT WERE TESTED USING A MULTIMETER. THE INSPIRATORY HEATER WIRE 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. THE EXPIRATORY HEATER WIRE WAS WITHIN SPECS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. 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 PRODUCTION, 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 WORLDWIDE FOR THE LAST YEAR OF 0.0025% TO AUGUST 2008.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED VIA FISHER & PAYKEL HEALTHCARE'S OFFICE THAT DURING EQUIPMENT SET-UP, AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT CAUSED THE HUMIDIFIER TO ALARM. IT SEEMS THAT THE RESISTANCE OF THE HEATER WIRE(S) IS TOO HIGH. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200 080404

    Patients

    Seq Age Sex Outcome Treatment
    1