BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT NASAL MASK

    MDR report key: 3893118 · Received June 25, 2014

    Report

    Report Number
    9611451-2014-00557
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 30, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FISHER & PAYKEL HEALTHCARE FLEXITRUNK INTERFACE IS DESIGNED TO DELIVER NON INVASIVE POSITIVE PRESSURE VENTILATION TO A SPONTANEOUSLY BREATHING PATIENT WEIGHING UP TO 10 KILOGRAMS IN A HOSPITAL OR CLINICAL SETTING WHERE THE PATIENT IS ADEQUATELY MONITORED BY TRAINED MEDICAL STAFF. THE BC800 NASAL MASK IS DESIGNED TO BE USED WITH THE FLEXITRUNK INTERFACE. AN INFANT BONNET IS USED TO KEEP THE FLEXITRUNK IN PLACE. THE COMPLAINT BC801 INFANT NASAL MASK WAS NOT RETURNED FOR EVALUATION, NOR WAS ANY FURTHER INFORMATION PROVIDED ABOUT THE NATURE OF THE "SORE" ON THE INFANT'S NOSE. NASAL TRAUMA CANNOT BE TOTALLY ELIMINATED WITH MASKS AND PRONGS DUE TO THE FRAGILE NATURE OF THE INFANT'S SKIN, BUT IT CAN BE MINIMISED WITH REGULAR CHECKING OF THE MASK OR PRONG POSITION WHILE IS USE IN AND BY FOLLOWING THE USER INSTRUCTIONS. THE USER INSTRUCTIONS THAT ACCOMPANY THE FISHER & PAYKEL HEALTHCARE INFANT INTERFACE INDICATE IN PICTORIAL FORM THE CORRECT SET-UP AND USE/FITTING OF INFANT INTERFACE DEVICES. THE FOLLOWING CHECKS ARE ALSO STATED IN THE USER INSTRUCTIONS: - CHECK PATIENT FREQUENTLY FOR SIGNS OF REDNESS, PRESSURE SORES OR IRRITATION WHICH MAY RESULT FROM EXTENDED PRONGS OR MASK USE. HOURLY CHECKS ARE RECOMMENDED. ALTERNATING BETWEEN MASK AND PRONGS CAN REDUCE THE RISK OF IRRITATION. ALTERNATING EVERY FOUR TO SIX HOURS IS RECOMMENDED. THE MASK SHOULD SIT COMFORTABLY AROUND THE PATIENT'S NOSE. NO MEDICAL OR SURGICAL INTERVENTION TO THE INFANT WAS REPORTED. IT IS POSSIBLE THAT OVERTIGHTENING OF THE BONNET STRAPS PLACED UNDUE PRESSURE ON THE INFANT'S NOSE. WE HAVE RECEIVED ONE OTHER COMPLAINT OF THIS NATURE FOR THE BC800 INFANT NASAL MASK IN THE PAST TWELVE MONTHS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN INFANT USING A BC801-10 NASAL MASK RECEIVED A WOUND ON THE BASE OF THE NOSE, FROM THE EDGE OF THE MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369750 INFANT NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LTD BC801

    Patients

    Seq Age Sex Outcome Treatment
    1