BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HEATED INSPIRATORY BREATHING CIRCUIT

    MDR report key: 1052714 · Received May 23, 2008

    Report

    Report Number
    9611451-2008-00293
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 24, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: IT IS LIKELY THE PART WAS 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 COMPLAINT SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE PAST YEAR OF 0.0026%.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR DISTRIBUTOR THAT AN ADAPTOR WAS MISSING FROM AN RT102 ADULT HEATED INSPIRATORY BREATHING CIRCUIT. THIS FAULT WAS DISCOVERED BY OUR DISTRIBUTOR DURING AN INWARD GOODS QUALITY INSPECTION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HEATED INSPIRATORY BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT102 080227

    Patients

    Seq Age Sex Outcome Treatment
    1