BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3233842 · Received July 18, 2013

    Report

    Report Number
    9611451-2013-00539
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    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 (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 OPT314 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 AND WAS MISSING. ADDITIONALLY, THE CANNULA WAS BROKEN IN HALF, BETWEEN THE NASAL PRONGS. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. CONCLUSION: THE HOSPITAL HAD INFORMED US THAT THE CANNULA HAD BROKEN IN HALF "WHEN STRETCHING TO RE-ATTACH". WE CAN CONCLUDE THAT THIS DAMAGE WAS THUS THE RESULT OF UNDUE FORCE BEING PLACED ON THE NECESSARILY DELICATE MATERIAL OF THE NASAL PRONGS. THE LEFT LOOP PAD (WIGGLEPAD) WAS NOT PROVIDED FOR EVALUATION SO WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED IT TO DETACH. LOOP PADS ARE BONDED TO THE INFANT OPTIFLOW CANNULA USING SPECIALISED PRIMER AND CYANOACRYLATE GLUE, IN ADDITION TO THE ADHESIVE ON THE LOOP PAD'S BACKING. THE BOND STRENGTH OF THE LOOP PADS TO THE CANNULA EXCEEDS THE BOND STRENGTH OF THE LOOP PADS TO THE HOOK ON THE WIGGLEPADS. 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 TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN OPT314 JUNIOR CANNULA BROKE IN HALF WHILE BEING REMOVED FROM A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335680 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT314 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1