BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO

    MDR report key: 1498499 · Received September 7, 2009

    Report

    Report Number
    9611451-2009-00485
    Event Type
    Malfunction
    Date Received
    September 7, 2009
    Date of Event
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K020332. THE ABNORMALITY WAS OBSERVED BY THE DISTRIBUTOR PRIOR TO PT USE. METHOD: THE RETURNED RT127 BREATHING CIRCUIT WAS VISUALLY INSPECTED. RESULTS: A 13 MILLIMETER LONG STRESS MARK WAS OBSERVED ON THE CUFF OF THE INSPIRATORY TUBE. A LOT CHECK REVEALED NO SIMILAR COMPLAINTS FOR CIRCUITS WITH A LOT NUMBER 090506. CONCLUSION: THE ROOT CAUSE OF THE STRESS MARK ON THE BREATHING CIRCUIT IS SLIGHT MOULDING DEFECT CAUSED BY MISALIGNMENT OF THE MOULDING TOOLS. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THEY OBSERVED A CRACK IN THE RT127 INFANT BREATHING CIRCUIT DURING THEIR INWARDS GOODS INSPECTION ACTIVITIES. AS THE ALLEGED DEFECT WAS OBSERVED BEFORE USE, THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO BTT FISHER & PAYKEL HEALTHCARE, LTD. RT127 090506

    Patients

    Seq Age Sex Outcome Treatment
    1