BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1061531 · Received June 17, 2008

    Report

    Report Number
    9611451-2008-00331
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 26, 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

    THE ELECTRICAL RESISTANCE OF THE HEATER WIRE IN THE INSPIRATORY LIMB OF THE BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: THE INSPIRATORY HEATER WIRE WAS FOUND TO BE AN OPEN CIRCUIT. THIS INDICATES THAT THERE IS A BREAK IN THE CIRCUIT BETWEEN THE HEATER WIRE AND ONE OF THE PINS THAT CRIMPS TO THE HEATER WIRE. 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. IMPROVEMENTS WERE MADE RECENTLY TO CRIMPING MACHINES ON THE PRODUCTION LINE. HOWEVER, AS NO LOT INFO WAS PROVIDED WITH THIS COMPLAINT, WE ARE NOT ABLE TO ASCERTAIN WHETHER THIS BREATHING CIRCUIT WAS MANUFACTURED BEFORE OR AFTER THE DATE OF IMPROVEMENTS. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0029%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO US THAT DURING THE SETTING UP OF THE RT105 ADULT BREATHING CIRCUIT TO A VENTILATOR, THE HEATER WIRE ALARM OF THE MR850 HUMIDIFIER ACTIVATED. IT SEEMED THAT THE HEATER WIRE OF THE BREATHING CIRCUIT WAS OPEN CIRCUIT. THE HOSPITAL STAFF REPLACED THE BREATHING CIRCUIT WITH A NEW ONE. NO PT CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT105

    Patients

    Seq Age Sex Outcome Treatment
    1