BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2007-00333

    MDR report key: 910792 · Received September 13, 2007

    Report

    Report Number
    9611451-2007-00333
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Report Date
    August 15, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREPARED BY REP. THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A HOSPITAL IN A FOREIGN COUNTRY. THE PRODUCT IS SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K020332.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY REPORTED THAT, THE INSPIRATORY TUBE OF AN RT225 BREATHING CIRCUIT DID NOT WARM UP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225

    Patients

    Seq Age Sex Outcome Treatment
    1 YR