BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT TRACHE DIRECT INTERFACE

    MDR report key: 4292593 · Received December 2, 2014

    Report

    Report Number
    9611451-2014-00902
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Report Date
    November 3, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING WAS PULLED APART. A LOT CHECK REVEALED NO OTHER COMPLAINT FOR THE LOT NUMBER PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE. HOWEVER, IT IS POSSIBLE THAT THE DEVICE MAY HAVE BEEN DISASSEMBLED OR PULLED APART. THE OPT870 INTERFACE IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A OPT870 TRACHEOSTOMY INTERFACE FELL APART WHILE IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT DESATURATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778761 ADULT TRACHE DIRECT INTERFACE BZA BZA FISHER & PAYKEL HEALTHCARE LTD OPT870 140716

    Patients

    Seq Age Sex Outcome Treatment
    1