BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2567014 · Received May 9, 2012

    Report

    Report Number
    9611451-2012-00289
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    March 26, 2012
    Report Date
    April 10, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT212 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: THE COMPLAINT RT212 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 110927. RESULTS: VISUAL INSPECTION REVEALED THAT BROWN PATIENT SECRETION WAS FOUND IN THE INSPIRATORY LIMB. NO INDICATION OF BURN WAS FOUND ON THE COMPLAINT DEVICE. CONCLUSION: WE WERE UNABLE TO CONFIRM THE REPORTED FAULT AS NO INDICATION OF BURN WAS FOUND WITH THE COMPLAINT DEVICE. THE PRESENCE OF PATIENT SECRETION IN THE COMPLAINT BREATHING CIRCUIT IS NOT UNUSUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT212 ADULT BREATHING CIRCUIT WAS "BURNED ALONG THE HEATER WIRE DURING USE." 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 LTD RT212 101008

    Patients

    Seq Age Sex Outcome Treatment
    1