BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2464601 · Received February 22, 2012

    Report

    Report Number
    9611451-2012-00099
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 26, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO THE MANUFACTURER. WE WILL SEND A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: A HEATER WIRE RESISTANCE TEST WAS CARRIED OUT USING A MULTIMETER. RESULTS: THE HEATER WIRE RESISTANCE OF BOTH THE INSPIRATORY AND EXPIRATORY LIMB OF THE RETURNED COMPLAINT DEVICE WAS FOUND TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. NO FAULT FOUND. CONCLUSION: NO FAULT WAS FOUND WITH RETURNED COMPLAINT BREATHING CIRCUIT. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE "AIRWAY TEMPERATURE" DID NOT INCREASE AFTER 5 DAYS WHILE USING AN RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE "AIRWAY TEMPERATURE" DID NOT INCREASE AFTER 5 DAYS WHILE USING AN RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT345 111103

    Patients

    Seq Age Sex Outcome Treatment
    1