BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1220358 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00647
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K983112. METHOD: THE ELECTRICAL RESISTANCE OF THE HEATER WIRE IN BOTH THE INSPIRATORY AND EXPIRATORY TUBES OF THE RT200 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. A LOT CHECK COULD NOT 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 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.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE MR850 RESPIRATORY HUMIDIFIER ISSUED A HEATER WIRE ALARM WHEN CONNECTED TO AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 HUMIDIFIER