BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2005096 · Received March 2, 2011

    Report

    Report Number
    9611451-2011-00111
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    January 20, 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)(4). 510(K): THE PRODUCT 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 DEVICE HAS NOT BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT 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 (B)(4). NARRATIVE: METHOD: THE RETURNED BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATERBATH TO CHECK FOR LEAKS. RESULTS: A LEAK WAS FOUND IN THE UNHEATED EXTENSION OF THE BREATHING CIRCUIT. A SMALL DEFECT WAS FOUND AT THE LOCATION OF THE LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070905. CONCLUSION: ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE LEAK DEVELOPED POST-PRODUCTION, POSSIBLY DURING TRANSPORT, STORAGE OR HANDLING/SETUP. THE COMPLAINT BREATHING CIRCUIT WAS MANUFACTURED IN 2007. A LEAK IN THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. THE RT125 USER INSTRUCTIONS STATE THE FOLLOWING: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT125 BREATHING CIRCUIT WAS LEAKING. THE LEAK WAS IDENTIFIED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT125 BREATHING CIRCUIT WAS LEAKING. THE LEAK WAS IDENTIFIED 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 070905

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR (MAKE, MODEL UNKNOWN)| VENTILATOR (MAKE, MODEL UNKNOWN)