BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1203454 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00619
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN ANOTHER COUNTRY. THE PRODUCT IS NOT SOLD IN THE USA, BUT A SIMILAR PRODUCT IS SOLD IN THE USA. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN BOTH THE INSPIRATORY AND EXPIRATORY TUBES OF THE BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: 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 OPERATING WITHIN PRODUCT SPECIFICATIONS. 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 FALL 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 EVENTS INVOLVING OPEN CIRCUIT HEATER WIRES IN BREATHING CIRCUITS HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 24PPM IN THE LAST YEAR TO 2008.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT BOTH INSPIRATORY AND EXPIRATORY TUBES OF AN ADULT DUAL-HEATED BREATHING CIRCUIT WERE NOT HEATING FOLLOWING 5 DAYS OF USE. NO PATIENT 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 080520

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RESPIRATORY| AUTOFEED HUMIDIFICATION CHAMBER| HUMIDIFIER