BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2149877 · Received July 5, 2011

    Report

    Report Number
    9611451-2011-00407
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Report Date
    June 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE (B)(4) 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. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION AND RETURN OF THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE RT225 BREATHING CIRCUIT KIT INCLUDES AN ADAPTOR KIT THAT CONSISTS OF 2 DRAEGER ADAPTORS. METHOD: THE COMPLAINT BREATHING CIRCUIT KIT WAS RETURNED AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED NO DAMAGE TO THE BREATHING CIRCUIT OR THE PACKAGING. ONE OF THE ADAPTORS APPEARED TO BE DEFORMED AS BOTH ENDS OF THE CONNECTOR ARE NOT ROUND PREVENTING CONNECTION OR INSERTION. NO FAULT WAS FOUND WITH THE OTHER ADAPTOR. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE LIKELIHOOD OF THE DEFORMATION OCCURRED WITH THIS CONNECTOR BEING ONE OF THE FIRST TO COME OFF THE MOULDING MACHINE AT THE START UP, RATHER THAN A DEFECT WITH ANY OF THE MOULDING TOOL. THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. ALL BREATHING CIRCUIT KITS AND ADAPTOR KITS ARE VISUALLY INSPECTED BEFORE LEAVING THE PRODUCTION LINE, ANY THAT FAIL THE VISUAL INSPECTION ARE DISCARDED. IT IS LIKELY THAT OPERATOR ERROR, DURING THE PACKING PROCESS, RESULTED IN THE DEFORMED ADAPTOR BEING INCLUDED IN THE BREATHING CIRCUIT KIT. PLEASE NOTE THAT THIS IS THE ONLY COMPLAINT THAT WE HAVE RECEIVED OF THIS NATURE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE CONNECTOR OF AN (B)(4) INFANT BIAS FLOW BREATHING CIRCUIT APPEARED TO BE "MELTED OR SHAPELESS", PREVENTING THE BREATHING CIRCUIT LIMBS TO BE CONNECTED. THE HOSPITAL HAS FURTHER REPORTED THAT THIS WAS AN ISOLATED EVENT AND THAT IT WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE CONNECTOR OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT APPEARED TO BE "MELTED OR SHAPELESS", PREVENTING THE BREATHING CIRCUIT LIMBS TO BE CONNECTED. THE HOSPITAL HAS FURTHER REPORTED THAT THIS WAS AN ISOLATED EVENT AND THAT IT WAS FOUND 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 LTD RT225 101202

    Patients

    Seq Age Sex Outcome Treatment
    1