BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR

    MDR report key: 2874834 · Received December 16, 2012

    Report

    Report Number
    9611451-2012-00908
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. THE INVESTIGATION OF THE COMPLAINT DEVICE IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PAEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. THE OPTIFLOW JUNIOR PROVIDES A REVOLUTIONARY STEP BETWEEN LOW-FLOW OXYGEN THERAPY AND CPAP. METHOD: THE COMPLAINT OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS RETURNED TO FISHER & PAKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE LEFT FLEXIBLE TUBE WAS DETACHED FROM THE CANNULA. NO DAMAGE WAS OBSERVED TO THE TUBE AND SUFFICIENT AMOUNT OF ADHESIVE WAS PRESENT ON THE EXTERNAL SURFACE OF THE TUBE WHICH IS INSERTED INTO THE CANNULA. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120328. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO THE OPT314 JUNIOR NASAL CANNULA. THE HOSPITAL PROVIDED ADDITIONAL INFORMATION THAT THE INFANT WAS TURNING FROM SIDE TO SIDE AND THE OPT314 WAS EASILY DISPLACED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT314 CANNULA STATE: "DO NOT STRETCH OR CRUSH TUBE." "PATIENT MONITORING IS RECOMMENDED."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) HAS REPORTED THAT THE TUBING WAS EASILY DISPLACED FROM THE CANNULA ON AN OPT314 OPTIFLOW JUNIOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) HAS REPORTED THAT THE TUBING WAS EASILY DISPLACED FROM THE CANNULA ON AN OPT314 OPTIFLOW JUNIOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA CAT FISHER & PAYKEL HEALTHCARE LTD OPT314 120328

    Patients

    Seq Age Sex Outcome Treatment
    1