BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2278227 · Received October 5, 2011

    Report

    Report Number
    9611451-2011-00616
    Event Type
    Malfunction
    Date Received
    October 5, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT102 ADULT INSPIRATORY HEATED BREATHING CIRCUIT 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 COMPLAINT RT102 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS RETURNED TO FPH (B)(4) FOR INVESTIGATION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE OF THE BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE OF THE RETURNED BREATHING CIRCUIT WAS FOUND TO HAVE ELECTRICAL RESISTANCE HIGHER THAN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 110228. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE FAILURE. HIGH RESISTANCE OR 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 THAT THE HEATER WIRE DEVELOPED THE FAULT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED VIA A DISTRIBUTOR THAT THERE WAS AN OPEN CIRCUIT ON AN RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT AND IT WAS NOT WARMING UP. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT102 110228

    Patients

    Seq Age Sex Outcome Treatment
    1