BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1340460 · Received January 19, 2009

    Report

    Report Number
    9611451-2009-00022
    Event Type
    Malfunction
    Date Received
    January 19, 2009
    Date of Event
    December 16, 2008
    Report Date
    December 17, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT 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. THE DEVICE IS EN ROUTE TO THE MANUFACTURER FOR INSPECTION. WE WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE HEATER WIRE OF AN RT106 ADULT BREATHING CIRCUIT WAS AN OPEN CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD. RT106 080626

    Patients

    Seq Age Sex Outcome Treatment
    1