BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3850168 · Received June 5, 2014

    Report

    Report Number
    9611451-2014-00485
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT312 OPTIFLOW JUNIOR INTERFACE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. THEREFORE OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL STAFF AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL REPORTED THAT THE TUBING PULLED AWAY FROM THE CIRCUIT CONNECTOR. NO FURTHER INFORMATION OR PHOTOGRAPHS WERE PROVIDED. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR FURTHER INFORMATION FROM THE HOSPITAL STAFF WE ARE UNABLE TO CONFIRM THE FAULT AS REPORTED BY THE CUSTOMER. ALL OPTIFLOW JUNIOR CANNULAE ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. IN ADDITION, SAMPLES ARE CURRENTLY TAKEN HOURLY FROM EACH RUN AND PULL TESTED TO CHECK GLUE JOINT STRENGTH AT THE CANNULA/TUBE JOINT, AS WELL AS THE SWIVEL GRIP JOINT (CIRCUIT CONNECTOR). IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PLACED ON HOLD FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORM THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: "DO NOT STRETCH OR CRUSH TUBE". "ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED." "APPROPRIATE MONITORING MUST BE USED AT ALL TIMES."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE OPT312 OPTIFLOW JUNIOR INTERFACE TUBING WAS PULLED AWAY FROM THE CIRCUIT CONNECTOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE OPT312 OPTIFLOW JUNIOR INTERFACE TUBING WAS PULLED AWAY FROM THE CIRCUIT CONNECTOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329821 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT312 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1