BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2133168 · Received June 19, 2011

    Report

    Report Number
    9611451-2011-00355
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT204 ADULT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. MANUFACTURER NARRATIVE: METHOD: THE SWIVEL Y-PIECE OF THE RETURNED RT204 ADULT BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR BLACK PARTICLES. RESULTS: VISUAL INSPECTION REVEALED THAT THE INSIDE OF THE SWIVEL Y-PIECE WAS STAINED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101216. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED PRIOR TO LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. IT IS MOST LIKELY THAT THE STAINED SWIVEL Y-PIECE WAS NOT PICKED UP DURING THE MANUAL ASSEMBLY OF THE RT204 ADULT BREATHING CIRCUIT IN THE PRODUCTION LINE. HOWEVER, WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE STAINS INSIDE THE SWIVEL. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT BLACK PARTICLE WAS FOUND INSIDE THE SWIVEL Y-PIECE OF AN RT204 ADULT DUAL-HEATED BREATHING CIRCUIT WHEN THE BLUE CAP WAS REMOVED FROM THE SWIVEL. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT204 101216

    Patients

    Seq Age Sex Outcome Treatment
    1