BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 1203450 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00615
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSPIRATORY TUBE OF THE RETURNED RT226 WAS VISUALLY EXAMINED FOR A DETACHED HEATER WIRE. RESULTS: THE SPIRAL HEATER WIRE ANCHORED INSIDE THE CORRUGATED INSPIRATORY TUBE BY A RETENTION CLIP, HAD BECOME UNHOOKED FROM THE CLIP WHILE THE RETENTION CLIP REMAINED IN PLACE. THIS CAUSED A SMALL RETRACTION OF THE HEATER WIRE WITHIN THE INSPIRATORY TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: AN ANALYSIS TO DETERMINE THE ROOT CAUSE OF HEATER WIRE RETRACTION IN BREATHING CIRCUITS IS CURRENTLY UNDERWAY. WE WILL PROVIDE A FOLLOW-UP REPORT AS SOON AS INVESTIGATION RESULTS BECOME AVAILABLE. OUR MONITORING AND TRENDING OF HEATER WIRE RETRACTION EVENTS IN INFANT BREATHING CIRCUITS HAS A RATE IN THE LAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT THE HEATER WIRE IN AN RT226 INFANT LOW BREATHING CIRCUIT "BROKE OUT OF THE BOND DURING USE." IT SEEMED THAT THE HEATER WIRE OF THE BREATHING CIRCUIT HAD DETACHED FROM ITS RETAINER CLIP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT LOW FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT226 080318

    Patients

    Seq Age Sex Outcome Treatment
    1