BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 3465470 · Received November 12, 2013

    Report

    Report Number
    9611451-2013-00905
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    October 5, 2013
    Report Date
    October 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT104 ADULT DUAL HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT104 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY AND THE EXPIRATORY HEATERWIRES WERE TESTED USING A CALIBRATED MULTIMETER. CONTINUITY TEST AND VISUAL INSPECTION WERE ALSO CONDUCTED TO CHECK THE ELECTRICAL CONNECTION BETWEEN THE HEATERWIRES AND THE HEATERWIRE PINS. RESULTS: ELECTRICAL RESISTANCE TEST SHOWED THE EXPIRATORY HEATERWIRE WAS WITHIN SPECIFICATION; HOWEVER, THE INSPIRATORY HEATERWIRE WAS OPEN CIRCUIT. CONTINUITY TEST AND VISUAL INSPECTION REVEALED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATERWIRE WAS LOCATED AT THE CONNECTION BETWEEN THE HEATERWIRE AND THE LEFT HEATERWIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130604. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION OF THE HEATERWIRE PIN DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT104 BREATHING CIRCUITS ARE RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE SUBJECT INSPIRATORY HEATERWIRE BECAME OPEN CIRCUIT AFTER RELEASED FOR DISTRIBUTION, POSSIBLY AS A RESULT OF INSUFFICIENT 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 OBSERVED WHEN THEY STARTED USING AN RT104 ADULT DUAL HEATED BREATHING CIRCUIT, WHICH WAS CONNECTED TO THE MR850 HUMIDIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581989 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT104 1306040304

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER