BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1030342 · Received April 15, 2008

    Report

    Report Number
    9611451-2008-00182
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Report Date
    March 13, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR INSPECTION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE OF SIMILAR COMPLAINTS. RESULTS: THE COMPONENT WAS MOST LIKELY OMITTED DURING OUR PACKING PROCESS. OUR RECORDS INDICATE THAT NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FOR THIS LOT NUMBER. CONCLUSION: OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE OF 0.0026% WORLDWIDE FOR THE LAST YEAR.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR REPORTED THAT A PART WAS MISSING FROM AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT. THIS WAS FOUND DURING THEIR INCOMING GOODS INSPECTION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT125 070423

    Patients

    Seq Age Sex Outcome Treatment
    1