BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINOUS FLOW BREATHING CIRCUIT

    MDR report key: 3223305 · Received July 12, 2013

    Report

    Report Number
    9611451-2013-00527
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT132 INFANT CONTINOUS FLOW BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A STRAIGHT AND CLEAN CUT IN THE RETURNED DRYLINE TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 121007. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE OBSERVED ON THE RETURNED DRYLINE TUBE. DRYLINE TUBES FOR ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED FOR ANY DAMAGE PRIOR TO BEING RELEASED FOR DISTRIBUTION. THE DRYLINE TUBE MAY HAVE BEEN DAMAGED WHEN THE CIRCUIT OR BOX WAS OPENED BY THE USER. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT132 INFANT CONTINOUS FLOW BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN RT132 INFANT CONTINOUS FLOW BREATHING CIRCUIT HAS A TEAR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323820 INFANT CONTINOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT132 121007

    Patients

    Seq Age Sex Outcome Treatment
    1