BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1172091 · Received September 18, 2008

    Report

    Report Number
    9611451-2008-00535
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    April 28, 2008
    Report Date
    August 19, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN (B) (4). 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 THE INSPIRATORY TUBE OF THE RT212 BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. A CONTINUITY TEST WAS ALSO PERFORMED ON THE HEATER WIRE CONNECTOR PINS TO TEST THE CONNECTIVITY OF THE PINS. 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 REVEALED ONE 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. (B) (4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED TO OUR DISTRIBUTOR THAT AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT CANNOT BE HEATED. NO PT 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. RT212 080702

    Patients

    Seq Age Sex Outcome Treatment
    1