BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 3238894 · Received July 21, 2013

    Report

    Report Number
    9611451-2013-00549
    Event Type
    Malfunction
    Date Received
    July 21, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE INSPIRATORY LIMB OF THE COMPLAINT RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE INSPIRATORY HEATERWIRE WAS RESISTANCE TESTED USING A MULTIMETER. CONTINUITY TEST WAS ALSO PERFORMED TO DETERMINE THE ELECTRICAL CONNECTION BETWEEN THE HEATERWIRE AND THE HEATERWIRE PINS. RESULTS: THE ELECTRICAL RESISTANCE TEST SHOWED THAT THE INSPIRATORY HEATERWIRE WAS WITHIN SPECIFICATION; HOWEVER, THERE WAS NO ELECTRICAL CONNECTION BETWEEN THE HEATERWIRE AND THE RIGHT HEATERWIRE PIN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130117. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATERWIRE DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT324 BREATHING CIRCUITS ARE RESISTANCE TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATERWIRE BECAME OPEN CIRCUIT AFTER RELEASED FOR DISTRIBUTION, POSSIBLY AS A RESULT OF AN INTERMITTENT 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 AN RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS DEFECTIVE. IT WAS FURTHER REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER, WHICH WAS USED IN CONJUNCTION WITH THE RT324 BREATHING CIRCUIT, WAS DISPLAYING A MAXIMUM TEMPERATURE OF 27.5°C. THIS WAS OBSERVED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS DEFECTIVE. IT WAS FURTHER REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIER, WHICH WAS USED IN CONJUNCTION WITH THE RT324 BREATHING CIRCUIT, WAS DISPLAYING A MAXIMUM TEMPERATURE OF 27.5Î THIS WAS OBSERVED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339323 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT324 130117

    Patients

    Seq Age Sex Outcome Treatment
    1