BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT DELIVERY SYSTEM

    MDR report key: 2152913 · Received July 7, 2011

    Report

    Report Number
    9611451-2011-00411
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC171 INFANT DELIVERY SYSTEM IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K100011. FISHER & PAYKEL HEALTHCARE WAS FIRST NOTIFIED VIA A PHONE CALL OF THIS INCIDENT ON (B)(6) 2011. A REPORT OF THIS INCIDENT FROM THE HOSPITAL STAFF WAS NOT RECEIVED UNTIL THE (B)(6) 2011. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. ATTEMPTS TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS INCIDENT HAS BEEN UNSUCCESSFUL. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND OUR KNOWLEDGE OF THE PRODUCT. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. THE HOSPITAL HAS REPORTED THAT HOSPITAL STAFF MEMBERS HAVE NOTED AT VARIOUS STAGES THE CONDITION OF THE PATIENT'S NARES OVER A 2 WEEK PERIOD. THE HOSPITAL HAS REPORTED ALTERNATING BETWEEN MASK AND PRONGS DEPENDING ON THE CONDITION OF THE NOSE. UP UNTIL THE 12TH DAY OF THERAPY, HOSPITAL STAFF NOTED THAT THE NOSE AT TIMES WAS SLIGHTLY RED, AND A DUODERM DRESSING WAS APPLIED. LATER ON THE 12TH DAY, IT WAS NOTED THAT THE NASAL SEPTUM WAS "PINK AND HEALTHY". ON THE 14TH DAY OF THERAPY, IT WAS NOTED THAT "SKIN ON THE NOSE WAS BROKEN" AND, DESPITE USING A MASK AND THE DUODERM DRESSING, THERE WAS EVIDENCE OF FURTHER BREAKDOWN AND AS A RESULT THE PATIENT WAS REINTUBATED. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS VISITED THE HOSPITAL UPON RECEIPT OF THIS COMPLAINT TO ORGANISE FURTHER TRAINING TO REITERATE USER INSTRUCTIONS. OUR USER INSTRUCTIONS ILLUSTRATE THE PROPER SET UP OF THE INTERFACES AND STATE THE FOLLOWING: "CHECK PATIENT FREQUENTLY FOR SIGNS OF REDNESS, PRESSURE SORES OR IRRITATION WHICH MAY RESULT FROM EXTENDED PRONG OR MASK USE. WE RECOMMEND HOURLY CHECKS. ALTERNATING BETWEEN MASK AND PRONGS CAN REDUCE THE RISK OF IRRITATION. ALTERNATING EVERY 4 TO 6 HOURS IS RECOMMENDED." "IF USING PRONGS: CLEAR NASAL SECRETIONS BEFORE INSERTING THE NASAL PRONGS. ENSURE THE NASAL PRONGS ARE POSITIONED AT LEAST 2MM FROM THE SEPTUM TO AVOID PRESSURE NECROSIS AND ADJUST AS NECESSARY. HOURLY CHECKS OF THE SEPTUM INTEGRITY ARE RECOMMENDED." "IF USING MASK: CONNECT TO PATIENT BY PLACING MASK AROUND 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 LIPS OR OVER THE EYES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE (B)(4) INFANT DELIVERY SYSTEM IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K100011. FISHER & PAYKEL HEALTHCARE WAS FIRST NOTIFIED VIA A PHONE CALL OF THIS INCIDENT ON (B)(6) 2011. A REPORT OF THIS INCIDENT FROM THE HOSPITAL STAFF WAS NOT RECEIVED UNTIL THE (B)(6) 2011. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS INCIDENT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THE FOLLOWING INFORMATION INVOLVING A (B)(4) INFANT DELIVERY SYSTEM - "AN INFANT WAS PLACED ON NCPAP ON (B)(6) 2011. NOSE BECAME SORE ON (B)(6) 2011 SO PLACED ON MASK TILL THE NEXT DAY, THEN BACK ON NCPAP. ON (B)(6) 2011 NOTED NOSE SLIGHTLY RED AND BY (B)(6) 2011 SHOWED EVIDENCE OF BREAKDOWN."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THE FOLLOWING INFORMATION INVOLVING A BC171 INFANT DELIVERY SYSTEM - "AN INFANT WAS PLACED ON NCPAP ON (B)(6) 2011. NOSE BECAME SORE ON (B)(6) 2011 SO PLACED ON MASK TILL THE NEXT DAY, THEN BACK ON NCPAP. ON (B)(6) 2011, NOTED NOSE SLIGHTLY RED AND BY (B)(6) 2011 SHOWED EVIDENCE OF BREAKDOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DELIVERY SYSTEM BZD BZD FISHER & PAYKEL HEALTHCARE LTD BC171 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention