BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3212189 · Received July 9, 2013

    Report

    Report Number
    9611451-2013-00520
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CANNULA IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    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 (WIGGLEPADS) 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 OPT316 JUNIOR CANNULA WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE AND WAS VISUALLY INSPECTED. RESULTS: INSPECTION OF THE CANNULA REVEALED THAT THE LOOP PAD (WIGGLEPAD PADDING) HAD BECOME DETACHED FROM THE LEFT SIDE OF THE CANNULA. GLUE WAS PRESENT ON THE CANNULA WHERE IT COMES IN CONTACT WITH THE LOOP PAD. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. CONCLUSION: THE LOOP PAD APPEARS TO HAVE DETACHED DUE TO FAILURE OF THE GLUE WHICH BONDS THE LOOP PAD'S ADHESIVE BACKING TO THE CANNULA. THE OPTIFLOW JUNIOR CANNULA MAINTAINS GOOD RETENTION ON THE INFANT'S FACE DURING USE. IT WOULD ONLY BE POSSIBLE FOR THE LOOP PAD TO BECOME DETACHED WHILE THE CANNULA IS BEING REMOVED BY THE CAREGIVER. THE USER INSTRUCTIONS THAT ACCOMPANY THE OPTIFLOW JUNIOR CANNULA SHOW IN PICTORIAL FORMAT HOW TO CORRECTLY REMOVE THE CANNULA AND ALSO CONTAIN THE FOLLOWING STATEMENT: CHECK CANNULA REMAINS SECURE ON THE FACE. REPLACE WIGGLEPADS IF REQUIRED. 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 RANGE OF CANNULAE BASED ON CUSTOMER FEEDBACK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE VELCRO GLUE ON THE WIGGLEPADS OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA FAILED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE VELCRO GLUE ON THE WIGGLEPADS OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA FAILED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314397 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT316

    Patients

    Seq Age Sex Outcome Treatment
    1