BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1009583 · Received March 7, 2008

    Report

    Report Number
    9611451-2008-00091
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    November 2, 2007
    Report Date
    January 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER AND PAKEL HEALTHCARE BY A DISTRIBUTOR. THE PRODUCT IS ALSO SOLD IN THE USA. LOT NUMBER 070713 WAS MANUFACTURED ON 7/13/2007. THE BREATHING CIRCUIT WAS TESTED USING A PRESSURE TESTER. IT WAS ALSO IMMERSED IN WATER TO DETERMINE THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE DROPPED BEYOND THE GIVEN LIMIT. THE LEAK CAME FROM THE WATER TRAP. LOT NUMBER 070628: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. LOT NUMBER 070713: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION: THE WATER TRAP WAS NOT SEALING CORRECTLY CAUSING A GAS LEAK TO OCCUR. EVERY BREATHING CIRCUIT IS PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE MALFUNCTION DEVELOPED AFTER THIS TIME. WE HAVE RECEIVED OTHER COMPLAINTS OF LEAKING CIRCUITS WITH AN OCCURRENCE RATE OF APPROX. 0.0025% WORLDWIDE FOR THE LAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT AN AIR LEAKAGE WAS OBSERVED IN RT134 ADULT BREATHING CIRCUIT WHILE SETTING UP TO THE VENTILATOR. THE LEAK TEST WAS CONDUCTED USING PRESSURE SET AT 210 CM H2O, BUT IT DROPPED TO 190 CM H2O. AIR LEAKAGE WAS DETECTED BETWEEN THE WATER TRAP CAP AND THE CUP. THIS WAS FOUND PRIOR TO USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT134 070628

    Patients

    Seq Age Sex Outcome Treatment
    1