BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2233865 · Received September 5, 2011

    Report

    Report Number
    9611451-2011-00543
    Event Type
    Malfunction
    Date Received
    September 5, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 6, 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 RT212 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 THA PRODUCT IS K983112. METHOD: THE COMPLAINT INSPIRATORY LIMB OF THE BREATHING CIRCUIT WAS RETURNED AND A HEATER WIRE RESISTANCE TEST WAS CARRIED OUT USING A MULTIMETER. RESULTS: THE HEATER WIRE RESISTANCE OF THE COMPLAINT INSPIRATORY LIMB WAS FOUND TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT INSPIRATORY LIMB. 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 AND CHAMBER TEMPERATURE DID NOT INCREASE WHILE SETTING UP AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT212

    Patients

    Seq Age Sex Outcome Treatment
    1