BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 855018 · Received May 25, 2007

    Report

    Report Number
    9611451-2007-00158
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN A FOREIGN COUNTRY. THE PRODUCT IS NOT SOLD IN USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. METHOD: NO SAMPLE PROVIDED. LOT NUMBER PROVIDED (061031). PHOTOGRAPHS PROVIDED (2). FROM PHOTOGRAPH IT CAN BE SEEN THAT THE BAG IS SEALED AND THE CONNECTOR IN QUESTION IS ABSENT FROM THE KIT. RESULTS: THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. THIS MISSING COMPONENT IS DUE TO OPERATOR ERROR IN THE PACKING PROCESS. CONCLUSION: THE DEVICE WAS OUT OF SPECIFICATION. THIS WILL BE BROUGHT TO THE ATTENTION OF MANUFACTURING TEAM MEMBERS. WE ARE AWARE OF OTHER SIMILAR COMPLAINTS. THE OCCURRENCE RATE IS APPROXIMATELY 0.0003% WORLDWIDE FOR THE LAST YEAR. WE WILL CONTINUE TO MONITOR ALL COMPLAINTS FOR SIMILAR FAULTS. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY REPORTED TO OUR DISTRIBUTOR THAT THERE WAS NO CONNECTOR PROVIDED WITH THE RT102 ADULT BREATHING CIRCUIT KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE RT102 061031

    Patients

    Seq Age Sex Outcome Treatment
    1 YR