BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1651091 · Received March 31, 2010

    Report

    Report Number
    9611451-2010-00195
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Report Date
    March 5, 2010
    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 RT227 IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A DEVICE THAT IS SOLD IN THE USA. THE 510 (K) FOR THE SIMILAR DEVICE IS K020332. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THEY WERE UNABLE TO CONNECT A HEATER WIRE ADAPTOR TO AN RT227 INFANT BREATHING CIRCUIT. THE REPORTED FAULT WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD RT227 090814

    Patients

    Seq Age Sex Outcome Treatment
    1 HEATER WIRE ADAPTOR