BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1052751 · Received May 23, 2008

    Report

    Report Number
    9611451-2008-00325
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFO WAS PROVIDED WITH THIS COMPLAINT. CONCLUSION: THE PRESSURE RELIEF VALVE WAS MOST LIKELY OMITTED DURING OUR PACKING PROCESS. WE HAVE AN OPEN CAPA ITEM TO ADDRESS SUCH COMPLAINTS AND TO PUT MEASURES IN PLACE TO REDUCE AND/OR PREVENT RECURRENCE. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE PAST YEAR OF 0.0026%.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT A PRESSURE RELIEF VALVE WAS MISSING FROM AN RT329 INFANT BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT329

    Patients

    Seq Age Sex Outcome Treatment
    1