BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT TRACHE DIRECT INTERFACE

    MDR report key: 4318142 · Received December 10, 2014

    Report

    Report Number
    9611451-2014-00912
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Report Date
    November 11, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT870 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 TRACHE. METHOD: THE COMPLAINT OPT870 WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. FURTHER INFORMATION WAS ALSO SOUGHT FROM THE CUSTOMER REGARDING HANDLING AND USE OF THE SUBJECT INTERFACE. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING AND CONNECTOR HAD BEEN PULLED APART. A LOT CHECK WAS NOT PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSION: THE CUSTOMER HAD INFORMED US THAT DRUGS WERE BEING NEBULISED BUT WAS NOT SURE WHICH DRUGS. ADDITIONALLY THEY STATED THAT IT WAS POSSIBLE THAT THE TUBING HAD BEEN ACCIDENTALLY PULLED APART. BASED ON THE EXTENT OF THE DAMAGE TO THE COMPLAINT INTERFACE IT IS LIKELY THAT IT HAS OCCURRED AS A RESULT OF EXCESSIVE PULLING FORCE BEING EXTERTED ON THE DEVICE. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT870 TRACHE INTERFACE STATE: TO ENSURE LOADING ON TRACHEOSTOMY TUBE IS KEPT TO A MINIMUM, MAKE SURE LANYARD IS FITTED APPROPRIATELY. DO NOT CRUSH OR STRETCH TUBE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN OPT870 TRACHEOSTOMY INTERFACE WAS RIPPED AT THE CONNECTION OF THE TUBING AND TRACHE CONNECTION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800830 ADULT TRACHE DIRECT INTERFACE BZA BZA FISHER & PAYKEL HEALTHCARE LTD OPT870

    Patients

    Seq Age Sex Outcome Treatment
    1