BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2192087 · Received August 4, 2011

    Report

    Report Number
    9611451-2011-00473
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 28, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT102 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 THE SIMILAR PRODUCT IS (B)(4). METHOD: ONLY THE INSPIRATORY TUBE OF THE COMPLAINT RT102 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH (B)(4) FOR INSPECTION. THE RETURNED INSPIRATORY TUBE WAS VISUALLY INSPECTED FOR ANY CONTAMINATIONS OR DISCOLOURATIONS. RESULTS: NO CONTAMINATION OR DISCOLOURATION WAS OBSERVED WITH THE RETURNED INSPIRATORY TUBE. CONCLUSION: EVERY BREATHING CIRCUIT IS VISUALLY INSPECTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY CONTAMINATION OR DISCOLOURATION. ANY BREATHING CIRCUIT WHICH FAILS THIS TEST IS REJECTED. THE TIMING OF USE SHOWS THAT THE DISCOLOURATION OBSERVED BY THE HOSPITAL OCCURRED POST PRODUCTION, AND IT IS MOST LIKELY DUE TO PATIENT SECRETIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT102 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 THE SIMILAR PRODUCT IS K983112. THE COMPLAINT RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVED THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WATER IN AN RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT WAS DISCOLOURED, APPEARING BLUE IN COLOUR. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE WATER IN AN RT102 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT WAS DISCOLOURED, APPEARING BLUE IN COLOUR. THIS WAS NOTICED 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 RT102 100923

    Patients

    Seq Age Sex Outcome Treatment
    1