BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1905284 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00707
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 INFANT BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. THE COMPLAINT RT225 INFANT BREATHING CIRCUITS WERE NOT RETURNED TO FPH FOR FURTHER INVESTIGATION. WITHOUT THE COMPLAINT DEVICES IT IS NOT POSSIBLE TO PROVIDE ANY REASONABLE CONCLUSIONS ABOUT THE REPORTED FAULT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT223 INFANT BREATHING CIRCUITS INCLUDE THE FOLLOWING STATEMENTS: "CHECK THAT THE HEATER WIRE IS EVENLY DISTRIBUTED ALONG THE CIRCUIT AND NOT BUNCHED OR KINKED." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. MANUFACTURER NARRATIVE: THE RT225 INFANT BIAS FLOW BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A QUANTITY OF FIVE RT225 INFANT BIAS FLOW BREATHING CIRCUIT WERE KINKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A QUANTITY OF FIVE RT225 INFANT BIAS FLOW BREATHING CIRCUIT WERE KINKED. THIS WAS OBSERVED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT225 100701

    Patients

    Seq Age Sex Outcome Treatment
    1