BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 3103386 · Received May 9, 2013

    Report

    Report Number
    9611451-2013-00372
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 RT225 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 K20332. METHOD: THE CONNECTOR OF THE COMPLAINT RT225 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). TWO DIFFERENT TEST TEMPERATURE/FLOW PROBES WERE INSERTED INTO THE COMPLAINT CONNECTOR TO CHECK FOR TIGHTNESS. RESULTS: BOTH TEST TEMPERATURE/FLOW PROBES WERE ABLE TO BE INSERTED INTO THE CONNECTOR OF THE COMPLAINT DEVICE AND THE FITMENT ON BOTH PROBES WERE FOUND TO BE TIGHT. NO DAMAGE WAS OBSERVED ON THE CONNECTOR OF THE COMPLAINT DEVICE. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED CONNECTOR OF THE COMPLAINT DEVICE. AS THE TEMPERATURE PROBE WAS NOT RETURNED, WE WERE UNABLE TO CONFIRM THE REPORTED FAULT AND DETERMINE THE CAUSE OF THE REPORTED EVENT. UNDER CORRECT SETUP, THE TEMPERATURE PROBE AND THE RT225 CIRCUIT COMPLY WITH (B)(4). THE USER INSTRUCTIONS THAT ACCOMPANY THE RT225 CIRCUIT CONTAIN A PICTORIAL DIAGRAM THAT INSTRUCTS THE USER TO CONNECT THE TEMPERATURE PROBE TO THE RT225 CIRCUIT "CONNECTLY". THIS USER INSTRUCTIONS ALSO STATE THE FOLLOWING: "CHECK THAT ALL CONNECTIONS ARE TIGHT BEFORE USE"; "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT"; "SET APPROPRIATE VENTILATOR ALARMS."

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 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 K20332. THE COMPLAINT RT225 CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE PRODUCT SPECIALIST THAT A "LOOSE CONNECTION" BETWEEN THE CIRCUIT PROBE PORT AND THE TEMPERATURE FLOW PROBE WAS OBSERVED ON AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT AFTER 7 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE PRODUCT SPECIALIST THAT A "LOOSE CONNECTION" BETWEEN THE CIRCUIT PROBE PORT AND THE TEMPERATURE FLOW PROBE WAS OBSERVED ON AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT AFTER 7 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203222 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225

    Patients

    Seq Age Sex Outcome Treatment
    1