BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT INSPIRATORY HEATED

    MDR report key: 835832 · Received March 29, 2007

    Report

    Report Number
    9611451-2007-00093
    Event Type
    Malfunction
    Date Received
    March 29, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    k983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO MFR BY A DISTRIBUTOR IN ANOTHER COUNTRY. THE PRODUCT IS NOT SOLD IN USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. AS WE WERE UNABLE TO GET THE SAMPLE BACK, WE EVALUATED SIMILAR COMPLAINTS AND THEIR INVESTIGATIONS.

    Description of Event or Problem · 1

    HOSPITAL IN ANOTHER COUNTRY REPORTED TO US THAT A LEAK HAD OCCURRED FROM THE WATER TRAP OF THE RT105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT INSPIRATORY HEATED BTT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT105 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *