BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 4220155 · Received November 3, 2014

    Report

    Report Number
    9611451-2014-00840
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR ANALYSIS IS BASED ON THE EVENT DESCRIPTION, PHOTOGRAPHS PROVIDED AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPH PROVIDED REVEALED THAT THE LEFT TUBE WAS DETACHED FROM THE CANNULA. THERE APPEARS TO BE NO DAMAGE TO THE TUBE. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: IT IS LIKELY THAT THE DAMAGE IS A RESULT OF EXCESSIVE FORCE DUE TO THE PATIENT PULLING ON THE DEVICE, AS REPORTED BY THE CUSTOMER. ALL OPTIFLOW JUNIOR CANNULAE ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. IN ADDITION, (B)(4). IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PLACED ON HOLD FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: "ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED." "APPROPRIATE MONITORING MUST BE USED AT ALL TIMES." "DO NOT STRETCH OR CRUSH TUBE."

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA BROKE DUE TO THE PATIENT PULLING ON THE CANNULA. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701537 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT318

    Patients

    Seq Age Sex Outcome Treatment
    1