BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 8747096 · Received July 1, 2019

    Report

    Report Number
    9611451-2019-00643
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Report Date
    June 1, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PS312515 D4 LOT #: 2100521419, 2100519585 H4 DEVICE MANUFACTURE DATE: 02 JUL 2018, 29 JUN 2018. FISHER & PAYKEL HEALTHCARE DID NOT RECEIVE A CANNULA FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON OUR KNOWLEDGE OF THE PRODUCT. THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PAEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS (WIGGLEPADS) TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. SPARE WIGGLEPADS ARE SOLD AS AN ACCESSORY FOR THE OPTIFLOW JUNIOR CANNULA UNDER THE PART NUMBER OPT012. WITHOUT THE RETURN OF A COMPLAINT DEVICE FOR EVALUATION WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE PROBLEM AS REPORTED BY THE HOSPITAL. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: - ENSURE SKIN IS DRY/PREPARED. - APPROPRIATE MONITORING MUST BE USED AT ALL TIMES. - CHECK CANNULA REMAINS SECURE ON THE FACE. REPLACE WIGGLEPADS IF REQUIRED.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN BRAZIL REPORTED ON BEHALF OF A HOSPITAL THAT THE WIGGLEPADS OF THE OPTIFLOW JUNIOR INTERFACES WERE NOT STICKING WELL TO THE PATIENT'S FACE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT #: 2100521419, 2100519585; DEVICE MANUFACTURE DATE: 02 JUL 2018, 29 JUN 2018. THE COMPLAINT DEVICES HAVE NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED ON BEHALF OF A HOSPITAL THAT THE WIGGLEPADS OF THE OPTIFLOW JUNIOR INTERFACES WERE NOT STICKING WELL TO THE PATIENT'S FACE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541764 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT318 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1