BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT MASK INTERFACE ADAPTER

    MDR report key: 11676207 · Received April 15, 2021

    Report

    Report Number
    9611451-2021-00403
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    March 18, 2021
    Product Code
    BZA
    UDI-DI
    09420012436948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE OPT980 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT980 CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE WHICH IS CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THE INTERFACE IS HELD IN PLACE BY A HEAD STRAP AND ALSO INCLUDES A LANYARD THAT IS PLACED AROUND THE PATIENT'S NECK OR ATTACHED TO THE PATIENT'S CLOTHING OR BEDDING TO REMOVE THE LOAD OF THE BREATHING CIRCUIT FROM THE PATIENT'S NARES. METHOD: THE COMPLAINT OPT980 OPTIFLOW + NASAL CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR INVESTIGATION. THEREFORE, OUR INVESTIGATION IS BASED OFF THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF PHOTOGRAPH PROVIDED BY THE CUSTOMER REVEALED THAT THE OPT944 OPTIFLOW + NASAL CANNULA WAS FOUND DETACHED FROM THE SWIVEL CONNECTOR. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. 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 DISPOSED OF OR REPROCESSED. THE SUBJECT OPT980 OPTIFLOW ADULT NASAL CANNULA WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE SETUP INSTRUCTIONS IN THE USER INSTRUCTIONS WHICH ACCOMPANY THE OPT980 OPTIFLOW + ADULT 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: "APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH." "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 · 0

    A DISTRIBUTOR IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT AN OPT980 MASK INTERFACE ADAPTER BROKE BETWEEN THE TUBING AND CONNECTOR. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT (B)(4) MASK INTERFACE ADAPTER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT AN OPT980 MASK INTERFACE ADAPTER BROKE BETWEEN THE TUBING AND CONNECTOR. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568236 ADULT MASK INTERFACE ADAPTER BZA BZA OPT980 2101310200 09420012436948

    Patients

    Seq Age Sex Outcome Treatment
    1