BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1182683 · Received September 25, 2008

    Report

    Report Number
    9611451-2008-00552
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    July 10, 2008
    Report Date
    September 1, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A FOREIGN DISTRIBUTOR. THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO PRODUCT WHICH IS SOLD IN THE USA. THE ELECTRICAL RESISTANCE OF THE HEATER WIRE IN THE INSPIRATORY TUBE OF THE RT106 BREATHING CIRCUIT WAS 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. A LOT CHECK REVEALED 1 OTHER COMPLAINT 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 HOSPITAL IN ANOTHER COUNTRY REPORTED TO OUR DISTRIBUTOR THAT A RESPIRATORY HUMIDIFIER ALARMED, WHEN HOSPITAL STAFF REPLACED THE EXISTING BREATHING CIRCUIT WITH AN ADULT INSPIRATORY HEATED BREATHING CIRCUIT. IT SEEMED THAT THIS WAS DUE TO AN OPEN CIRCUIT HEATER WIRE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD. RT106 080626

    Patients

    Seq Age Sex Outcome Treatment
    1