BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW TRACHEOSTOMY DIRECT CONNECTION

    MDR report key: 2855042 · Received December 3, 2012

    Report

    Report Number
    9611451-2012-00863
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 9, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT570 OPTIFLOW TRACHEOSTOMY DIRECT CONNECTION INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS VIA TRACHEOSTOMY. THE INTERFACE IS HELD IN PLACE BY A NECK STRAP AND ALSO INCLUDES A LANYARD WHICH IS PLACED AROUND THE PATIENT'S NECK OR ATTACHED TO THE PATIENT'S CLOTHING OR BEDDING TO REMOVE THE LOAD OF THE BREATHING CIRCUIT FROM THE PATIENT'S TRACHEA. METHOD: ONE OF THE THREE COMPLAINT OPT570 INTERFACES WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE BREATHABLE FILM OF THE OPT570 TUBING WAS PULLED APART, CONFIRMING THE REPORTED FAULT. A LOT CHECK WAS NOT PERFORMED AS LOT NUMBER WAS NOT PROVIDED. CONCLUSION: THE DAMAGE APPEARED TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE BREATHING CIRCUIT CONNECTOR. ALL OPT570 INTERFACES ARE VISUALLY INSPECTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE DAMAGE OCCURRED POST PRODUCTION. FISHER & PAYKEL HEALTHCARE USER INSTRUCTIONS THAT ACCOMPANY THE OPT570 INTERFACE SPECIFY IN THE WARNING SECTION "DO NOT CRUSH OR STRETCH THE TUBE". (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THREE OPT570 OPTIFLOW TRACHEOSTOMY DIRECT CONNECTION INTERFACES WERE "DAMAGED BEHIND CONNECTOR, FRAYING OF THE MATERIAL BETWEEN THE SPINES OF THE TUBE". THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLOW TRACHEOSTOMY DIRECT CONNECTION BZA BTT FISHER & PAYKEL HEALTHCARE LIMITED OPT570 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1