BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3233096 · Received July 18, 2013

    Report

    Report Number
    9611451-2013-00538
    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. FISHER & PAYKEL DID NOT RECEIVE A CANNULA FOR EVALUATION AND WE WERE INFORMED THAT THE HOSPITAL HAD DISCARDED THE SUBJECT CANNULA. WITHOUT A DEVICE WE WERE UNABLE TO DETERMINE WHETHER THERE WAS AN ACTUAL DEFECT WITH THE VELCRO ON THE WIGGLEPADS OF THE CANNULA. THE HOSPITAL HAD INFORMED US THAT THE PATIENT WAS BEING TREATED WITH SURECLEANSE FOR A RASH, AND THAT THIS HAD BEEN RUBBED ALL OVER THE CHILD'S FACE OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPTIFLOW JUNIOR NASAL CANNULA CONTAIN THE FOLLOWING INSTRUCTION WITH REGARD TO PLACING OF THE WIGGLEPADS: ENSURE SKIN IS DRY/PREPARED. ADDITIONALLY THE OPTIFLOW JUNIOR NASAL CANNULA FITTING GUIDE CONTAINS THE FOLLOWING STATEMENT: ENSURE INFANT'S SKIN IS CLEAN AND DRY. FOLLOW YOUR HOSPITAL'S PROTOCOL FOR SKIN PREPARATION. 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. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE VELCRO ON THE OPTIFLOW JUNIOR INTERFACE BECAME DETACHED DURING USE. NO PATIENT CONSENQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336055 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT312 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1