BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3898471 · Received June 26, 2014

    Report

    Report Number
    9611451-2014-00551
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CANNULA WAS RECEIVED AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE CANNULA REVEALED THAT THE TUBING HAD BEEN PULLED AWAY FROM THE SWIVEL GRIP. A LOT CHECK REVEALED NO SIMILAR COMPLAINTS FOR LOT NUMBER 130911. CONCLUSION: BASED ON THE OBSERVED DAMAGE, WE CAN CONCLUDE THAT THE TUBING BECAME DAMAGED DUE TO EXCESSIVE FORCE BEING EXERTED ON THE TUBING. EACH OPTIFLOW JUNIOR CANNULA IS LEAK, OCCLUSION AND TENSILE STRENGTH TESTED ON THE PRODUCTION LINE AND ANY THAT FAIL ARE DISCARDED. (B)(4). OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPTIFLOW JUNIOR CANNULA STATE: ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED. UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES BEING TRANSFERRED TO THE PATIENT. PATIENT MONITORING IS RECOMMENDED. DO NOT STRETCH OR CRUSH TUBE. 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 A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN OPT318 OPTIFLOW JUNIOR NASAL CANNULA TORE WHERE IT CONNECTS TO THE CIRCUIT. THIS OCCURRED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373258 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT318 130911

    Patients

    Seq Age Sex Outcome Treatment
    1