BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR ADAPTOR KIT

    MDR report key: 5618892 · Received April 29, 2016

    Report

    Report Number
    9611451-2016-00157
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    December 21, 2015
    Report Date
    December 22, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT016 OPTIFLOW JUNIOR ADAPTOR KIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. DESPITE FOLLOWING UP WITH THE CUSTOMER THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE OPT016 ADAPTOR WOULD NOT STAY ON THE 900PT531 TUBING. IT WAS REPORTED THAT THIS OCCURRED AFTER FOUR DAYS OF USE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140728. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. IF THE COMPLAINT DEVICE WAS RETURNED IT WOULD'VE BEEN VISUALLY INSPECTED FOR ANY DAMAGE. THIS IS THE ONLY COMPLAINT OF THIS NATURE WE HAVE RECEIVED FOR THE OPT016. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPT016. THEY ALSO STATE THE FOLLOWING: CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE. APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN OPT016 OPTIFLOW JUNIOR ADAPTOR KIT WAS USED WITH A 900PT531 OPTIFLOW JUNIOR TUBING AND CHAMBER KIT AND AFTER FOUR DAYS OF USE THE OPT016 WOULD NOT STAY ON THE 900PT531. THEY FURTHER REPORTED THAT UPON REPLACING THE OPT016 THIS ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277086 OPTIFLOW JUNIOR ADAPTOR KIT BZA BZA FISHER & PAYKEL HEALTHCARE LTD OPT016 140728

    Patients

    Seq Age Sex Outcome Treatment
    1