BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3230569 · Received July 16, 2013

    Report

    Report Number
    9611451-2013-00530
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PAEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. THE OPTIFLOW JUNIOR PROVIDES A REVOLUTIONARY STEP BETWEEN LOW-FLOW OXYGEN THERAPY AND CPAP. METHOD: THE COMPLAINT CANNULA WAS NOT RECEIVED IN (B)(4) FOR EVALUATION. WE WERE INFORMED THAT THE COMPLAINT DEVICE WAS LOST IN TRANSIT TO (B)(4). OUR INVESTIGATION IS THUS BASED ON A PHOTOGRAPH OF THE COMPLAINT DEVICE SUPPLIED BY OUR (B)(4) OFFICE. RESULTS: INSPECTION OF THE SUPPLIED PHOTOGRAPH REVEALED THAT THE TUBING HAD BECOME DETACHED FROM THE RIGHT HAND SIDE OF THE MANIFOLD. CONCLUSION: WITHOUT THE COMPLAINT DEVICE WE WERE UNABLE TO CONFIRM WHETHER SUFFICIENT GLUE HAD BEEN APPLIED. EACH CANNULA IS LEAK AND OCCLUSION TESTED AT THE PRODUCTION LINE AND ANY THAT FAIL ARE DISCARDED. IN ORDER TO CHECK THE GLUE BOND, AN ASSEMBLED SAMPLE IS PULL TESTED AT THE END OF EACH RUN AFTER ALLOWING IT TO DRY FOR AT LEAST THREE HOURS. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPTIFLOW JUNIOR CANNULA STATE: ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED. UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES BEING TRANSFERRED TO THE PATIENT. PATIENT MONITORING IS RECOMMENDED. FISHER & PAYKEL HEALTHCARE MAINTAINS A CLOSE SUPERVISION OF THIS PRODUCT AND ITS BEHAVIOUR IN THE FIELD IN ORDER TO GAIN INFORMATION. WE ARE CONTINUOUSLY WORKING TO IMPROVE THE OPTIFLOW JUNIOR CANNULA BASED ON CUSTOMER FEEDBACK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TUBING ON THE OPT312 JUNIOR INTERFACE HAD BECOME DETACHED FROM THE CANNULA DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329203 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT312

    Patients

    Seq Age Sex Outcome Treatment
    1