BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2005098 · Received March 2, 2011

    Report

    Report Number
    9611451-2011-00113
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    January 29, 2011
    Report Date
    February 8, 2011
    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)(6). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THIS PRODUCT IS K020332. METHOD: IT WAS REPORTED THAT THE COMPLAINT BREATHING CIRCUITS WOULD BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION, HOWEVER THE CIRCUITS HAVE NOT BEEN RECEIVED. AN INVESTIGATION WAS CARRIED OUT BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. RESULTS: THE CUSTOMER REPORTED THAT THE CIRCUITS WERE LEAKING NEAR THE ADAPTOR. IT WAS REPORTED THAT THE CONNECTION APPEARED TO BE MOVING ABNORMALLY. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT BREATHING CIRCUITS FOR EVALUATION, WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED LEAKS. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE RT125 BREATHING CIRCUIT USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENTS: CHECK 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. FISHER & PAYKEL HEALTHCARE HAS RECEIVED NO OTHER COMPLAINTS FOR RT125 BREATHING CIRCUITS WITH LOT NUMBER 100707.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THIS PRODUCT IS (B)(4). METHOD: SIX COMPLAINT BREATHING CIRCUITS HAVE SUBSEQUENTLY BEEN RECEIVED SINCE THE FINAL REPORT WAS SENT. THE SIX RETURNED COMPLAINT BREATHING CIRCUITS WERE VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE VISUAL INSPECTION REVEALED NO DAMAGES TO THE SIX COMPLAINT BREATHING CIRCUITS. THE PRESSURE TEST REVEALED THAT ALL SIX COMPLAINT BREATHING CIRCUITS WERE WITHIN SPECIFICATION FOR THIS PRODUCT. CONCLUSION: NO FAULT WAS FOUND FOR ALL SIX RETURNED COMPLAINT BREATHING CIRCUITS. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE RT125 BREATHING CIRCUIT USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENTS: CHECK 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. FISHER & PAYKEL HEALTHCARE HAS RECEIVED NO OTHER COMPLAINTS FOR RT125 BREATHING CIRCUITS WITH LOT NUMBER 100707.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THIS PRODUCT IS K020332. THE SIX COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT SIX RT125 BREATHING CIRCUITS WERE LEAKING AT THE ADAPTORS. IT WAS ALSO REPORTED THAT THE MOVEMENT OF THE CONNECTION APPEARED ABNORMAL. THE LEAKS AND ABNORMAL MOVEMENTS WERE OBSERVED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT SIX RT125 BREATHING CIRCUITS WERE LEAKING AT THE ADAPTORS. IT WAS ALSO REPORTED THAT THE MOVEMENT OF THE CONNECTION APPEARED ABNORMAL. THE LEAKS AND ABNORMAL MOVEMENTS WERE OBSERVED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT SIX RT125 BREATHING CIRCUITS WERE LEAKING AT THE ADAPTORS. IT WAS ALSO REPORTED THAT THE MOVEMENT OF THE CONNECTION APPEARED ABNORMAL. THE LEAKS AND ABNORMAL MOVEMENTS WERE OBSERVED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT125 100707

    Patients

    Seq Age Sex Outcome Treatment
    1