BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 6671661 · Received June 27, 2017

    Report

    Report Number
    9611451-2017-00592
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Report Date
    May 30, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). G5 PMA/510(K): THE RT224 INFANT CONTINUOUS FLOW 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 K020332. THE COMPLAINT RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. THE INFORMATION PROVIDED BY THE HOSPITAL WAS INSUFFICIENT FOR US TO DRAW ANY REASONABLE CONCLUSION REGARDING THE CAUSE OF THE REPORTED LEAK. WITHOUT THE SUBJECT INFANT BREATHING CIRCUIT, WE WERE UNABLE TO DETERMINE IF IT HAD A MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LEAK, OR IDENTIFY ITS ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT224 INFANT CONTINUOUS FLOW 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 K020332. MANUFACTURER NARRATIVE WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL VIA THE DISTRIBUTOR TO DETERMINE IF THE COMPLAINT RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE ARE ALSO ATTEMPTING TO OBTAIN THE SUBJECT COMPLAINT DEVICE FOR FURTHER INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR EVALUATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT WAS FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451949 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT224 2100082770

    Patients

    Seq Age Sex Outcome Treatment
    1