BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 2395997 · Received January 3, 2012

    Report

    Report Number
    9611451-2012-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 18, 2011
    Report Date
    December 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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. WE ARE CURRENTLY ENDEAVOURING TO RETRIEVE THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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. METHOD: A HEATER WIRE RESISTANCE TEST WAS CARRIED OUT USING A MULTIMETER. RESULTS: THE HEATER WIRE RESISTANCE TEST REVEALED BOTH THE INSPIRATORY AND EXPIRATORY LIMBS TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE. CONCLUSION: NO FAULT WAS FOUND. 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 AN RT100 ADULT DUAL HEATED BREATHING CIRCUIT CAUSED THE (B)(4) RESPIRATORY HUMIDIFIER TO ALARM WHEN CONNECTED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT100 ADULT DUAL HEATED BREATHING CIRCUIT CAUSED THE MR850 RESPIRATORY HUMIDIFIER TO ALARM WHEN CONNECTED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT100 111123

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| MR850 RESPIRATORY HUMIDIFIER