BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 6088165 · Received November 8, 2016

    Report

    Report Number
    9611451-2016-00756
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    October 12, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT946 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS AND CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THE INTERFACE IS HELD IN PLACE BY A HEAD STRAP AND FEATURES A HEAD STRAP CLIP WHICH WORKS IN TANDEM WITH THE TUBING CLIP (ATTACHES TO THE PATIENT'S CLOTHING/BEDDING) TO SUPPORT THE WEIGHT OF THE CIRCUIT AND PREVENT THE CANNULA BEING DISLODGED. METHOD: THE COMPLAINT CANNULA WAS RETURNED TO FISHER & PAYKEL HEALTHCARE AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE SUBJECT CANNULA REVEALED THAT IT APPEARED WELL WORN AND EXTENSIVELY DAMAGED. THE TUBING WAS DETACHED FROM THE (DISTAL) SWIVEL CONNECTOR. THE TUBING WAS FOUND TO BE PARTLY TORN NEAR THE MANIFOLD. THE CANNULA WAS PARTLY DETACHED FROM THE LEFT SIDE OF THE MANIFOLD. THE CANNULA WAS DISCOLOURED YELLOW INSTEAD OF THE NORMAL WHITE. CONCLUSION: THE OBSERVED DAMAGE IS MOST LIKELY THE RESULT OF PULLING ON THE CANNULA TUBING WITH UNDUE FORCE. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF. THE SETUP INSTRUCTIONS IN THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT946 NASAL CANNULA INCLUDE THE FOLLOWING STEPS: ENSURE HEAD STRAP CLIP IS ATTACHED, TO PREVENT CANNULA FROM BEING PULLED OUT OF THE NARES. CANNULA CAN BECOME UNATTACHED IF NOT USED WITH THE HEAD STRAP CLIP. ATTACH TUBING CLIP TO CLOTHING/BEDDING TO PREVENT CANNULA FROM PULLING OFF FACE. THE USER INSTRUCTIONS ALSO CONTAIN THE FOLLOWING WARNINGS/CAUTIONS: DO NOT CRUSH OR STRETCH TUBE, TO PREVENT LOSS OF THERAPY. FAILURE TO USE THE SET-UP DESCRIBED ABOVE CAN COMPROMISE PERFORMANCE AND AFFECT PATIENT SAFETY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TUBING OF AN OPT946 NASAL CANNULA 'CAME APART' FROM THE CONNECTOR. NO PATIENT CONSEQUENCE WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737339 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT946

    Patients

    Seq Age Sex Outcome Treatment
    1