BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUITS

    MDR report key: 3516260 · Received December 11, 2013

    Report

    Report Number
    9611451-2013-01005
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 22, 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 RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT SOLD IN THE USA WITH A 510(K) OF K983112. METHOD: THE COMPLAINT RT105 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATERWIRE WAS TESTED USING A CALIBRATED MULTIMETER. CONTINUITY TEST AND VISUAL INSPECTION WERE ALSO CONDUCTED TO CHECK THE ELECTRICAL CONNECTION BETWEEN THE HEATERWIRE AND THE HEATERWIRE PINS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT. THE ELECTRICAL RESISTANCE TEST SHOWED 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 RIGHT HEATERWIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130626. 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 RT105 BREATHING CIRCUITS ARE ELECTRICAL 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 "HEATERWIRE DISCONNECT" ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER WHEN AN RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS CONNECTED. THIS WAS OBSERVED AFTER ONE WEEK OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648480 ADULT INSPIRATORY HEATED BREATHING CIRCUITS BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT105 130626

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER