BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2305906 · Received October 24, 2011

    Report

    Report Number
    9611451-2011-00652
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    September 17, 2011
    Report Date
    September 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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: ONLY THE INSPIRATORY TUBE OF THE COMPLAINT RT102 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS TESTED USING A MULTIMETER. RESULTS: THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS OUT OF SPECIFICATION. THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT DUE TO A BREAK IN CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE PINS THAT CRIMPS TO THE HEATER WIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110413. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE 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 OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A "HEATER WIRE DISCONNECT ALARM" SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER. THIS WAS NOTICED DURING USE ON A PATIENT. IT WAS CONFIRMED THAT THERE WAS AN OPEN CIRCUIT ON AN RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT102 110413

    Patients

    Seq Age Sex Outcome Treatment
    1