BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT NASAL MASK

    MDR report key: 5992894 · Received October 2, 2016

    Report

    Report Number
    9611451-2016-00624
    Event Type
    Malfunction
    Date Received
    October 2, 2016
    Report Date
    September 3, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE COMPLAINT BC802 INFANT NASAL MASK WAS RETURNED TO (B)(6) IN CONJUNCTION WITH A BC192-05 FLEXITRUNK INFANT NASAL TUBING AND WERE VISUALLY INSPECTED. THE DIMENSIONS OF THE MASK AND THE MIDLINE CANNULA HOUSING WERE ALSO MEASURED AND COMPARED AGAINST THE DRAWING SPECIFICATIONS. THE COMPLAINT BC802 NASAL MASK HAD ALSO UNDERGONE A DOUBLE LOADING TEST BY FITTING IT TO THE RETURNED BC192 NASAL TUBING AND ATTACHING ANOTHER SAMPLE OF BC802 NASAL MASK TO THE COMPLAINT BC802 NASAL MASK. A GAS FLOW OF 8 LITERS PER MINUTE WAS SUBSEQUENTLY APPLIED TO THE SET-UP FOR SIX HOURS. RESULTS: THE DIMENSIONS WERE ALL WITHIN SPECIFICATIONS. THE MIDLINE CANNUAL HOUSING WAS ABLE TO RETAIN TWICE THE MASK'S WEIGHT WITHOUT DETACHING FROM THE SET-UP. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. CONCLUSION: NO FAULT WAS FOUND TO THE RETURNED BC192 FLEXITRUNK INFANT NASAL TUBING AND BC802 INFANT NASAL MASK. THE USER INSTRUCTIONS THAT ACCOMPANY THE FLEXITRUNK INFANT INTERFACE ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF INFANT INTERFACES, INCLUDING THE NASAL MASK AND NASAL TUBING. IT ALSO STATES THE FOLLOWING: - "CONNECT PRONGS AND MASK TO NASAL TUBING ENSURING THAT IT IS INSERTED FULLY." - "IF USING MASK: CONNECT TO PATIENT BY PLACING MASK AROUND THE NOSE. THE MASK SHOULD SIT COMFORTABLY AROUND THE PATIENT'S NOSE. IT MUST NOT OCCLUDE THE NOSTRILS OR TOUCH THE SEPTUM AND SHOULD NOT BE OVER THE LIP OR OVER THE EYES." - "CHECK THAT ALL CIRCUIT CONNECTIONS ARE TIGHT BEFORE USE AND AFTER ANY ADJUSTMENT."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BC802 INFANT NASAL MASK WAS RECENTLY RETURNED TO FPH IN (B)(4) FOR EVALUATION, TO DETERMINE IF IT HAD A MALFUNCTION WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THEIR BC802 INFANT NASAL MASKS WERE DISCONNECTING EASILY. NO PATIENT CONSEQUENCE WAS REPORTED AS NO SPECIFIC INCIDENT WAS REPORTED. THIS WAS A GENERAL COMPLAINT REPORTED BY THE HEALTHCARE FACILITY TO AN FPH REPRESENTATIVE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENATIVE THAT THEIR BC802 INFANT NASAL MASKS WERE DISCONNECTING EASILY. NO PATIENT CONSEQUENCE WAS REPORTED AS NO SPECIFIC INCIDENT WAS REPORTED. THIS WAS A GENERAL COMPLAINT REPORTED BY THE HEALTHCARE FACILITY TO AN FPH REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644265 INFANT NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LTD BC802

    Patients

    Seq Age Sex Outcome Treatment
    1 FLEXITRUNK INFANT NASAL TUBING