BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 5382706 · Received January 21, 2016

    Report

    Report Number
    9611451-2016-00022
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    December 21, 2015
    Report Date
    December 22, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THEREFORE, OUR INVESTIGATIONS IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE OPT846 ADULT NASAL CANNULA WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140908. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE AND ANY FURTHER INFORMATION FROM THE CUSTOMER WE ARE UNABLE TO CONFIRM THE REPORTED PROBLEM. IF THE COMPLAINT DEVICE WAS RETURNED IT WOULD HAVE BEEN VISUALLY INSPECTED FOR THE REPORTED DAMAGE. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISCARDED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN OPT846 ADULT NASAL CANNULA WAS DAMAGED NEAR THE NASAL CANNULA. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN OPT846 ADULT NASAL CANNULA WAS DAMAGED NEAR THE NASAL CANNULA. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42314 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT846 140908

    Patients

    Seq Age Sex Outcome Treatment
    1