BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2042763 · Received April 6, 2011

    Report

    Report Number
    9611451-2011-00220
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 10, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K). THE RT205 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. MANUFACTURER NARRATIVE. THE COMPLAINT RT205 ADULT INSPIRATORY-HEATER BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT205 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS (B)(4). METHOD: THE RETURNED RT205 BREATHING CIRCUIT WAS PRESSURE TESTED AND IMMERSED IN A WATERBATH TO CHECK FOR LEAKS. RESULTS: THE PRESSURE TEST RESULT WAS OUTSIDE THE REQUIRED SPECIFICATION. IMMERSION IN A WATERBATH SHOWED THE LOCATION OF THE LEAK TO BE BETWEEN THE LID AND BOWL OF THE WATER TRAP. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101220. CONCLUSION: A LEAK IN THE WATER TRAP OF THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAKS MUST HAVE DEVELOPED POST PRODUCTION. THE USER INSTRUCTIONS FOR RT205 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARM." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AIR LEAKED FROM THE WATER TRAP OF AN RT205 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AIR LEAKED FROM THE WATER TRAP OF AN RT205 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT205 101220

    Patients

    Seq Age Sex Outcome Treatment
    1