BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1374612 · Received April 16, 2009

    Report

    Report Number
    9611451-2009-00191
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Date of Event
    March 13, 2009
    Report Date
    March 16, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE SIMILAR PRODUCT IS K983112. THE DEVICE IS EN ROUTE TO THE MANUFACTURER FOR INSPECTION. WE WILL PROVIDE A FOLLOW UP REPORT AFTER COMPLETING OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE HEATER WIRE FAILED IN THE EXPIRATORY TUBE OF AN RT200 ADULT BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200

    Patients

    Seq Age Sex Outcome Treatment
    1