BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1026691 · Received April 3, 2008

    Report

    Report Number
    9611451-2008-00128
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Report Date
    January 29, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN ANOTHER COUNTRY. THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. ADDITIONAL LOT NUMBERS ARE 070904 AND 071116. ADDITIONAL MANUFACTURING DATES ARE 09/04/2007 AND 11/16/2007. AN INVESTIGATION WILL BE CARRIED OUT ONCE WE RECEIVE THE COMPLAINT DEVICE. RESULTS: NO RESULTS TO DATE. LOT NUMBER 071004: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 071116: OUR RECORDS INDICATE THAT TWO COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION: NO CONCLUSION CAN BE PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT DURING THE INSPECTION OF RT227 INFANT BREATHING CIRCUIT, SOME CIRCUITS WERE FOUND WITH FRESH GAS PORT PLUGS NOT INSERTED. THIS WAS FOUND PRIOR TO USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT227 071004

    Patients

    Seq Age Sex Outcome Treatment
    1