BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3010390 · Received March 19, 2013

    Report

    Report Number
    9611451-2013-00199
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FISHER & PAYKEL DID NOT RECEIVE THE COMPLAINT CANNULA. WE WERE INFORMED THAT THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION. RESULTS: A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 121026. CONCLUSION: WITHOUT THE COMPLAINT DEVICE WE WERE UNABLE TO CONFIRM WHAT HAD CAUSED THE PROBLEM AS REPORTED BY THE HOSPITAL. 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. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT316 CANNULA STATE: UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES BEING TRANSFERRED TO THE PATIENT. ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE 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 OPT318 BASED ON CUSTOMER FEEDBACK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS PULLED APART BY A (B)(6). NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113948 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT318 121026

    Patients

    Seq Age Sex Outcome Treatment
    1