BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BONNET MIDLINE

    MDR report key: 2092601 · Received May 18, 2011

    Report

    Report Number
    9611451-2011-00299
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION, FURTHER INFORMATION FROM THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. IT HAS BEEN REPORTED THAT THERE HAVE BEEN INSTANCES WHEN THE VELCRO HAS BEEN LEFT UNATTACHED, OR GLUED IN A DIFFERENT POSITION TO EXTEND THE LENGTH OF THE STRAPS. HOWEVER, WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE PROBLEM OBSERVED BY THE CUSTOMER. OUR USER INSTRUCTION ILLUSTRATES AND STATES: "DO NOT MODIFY THIS PRODUCT." "PLACE THE STRAP OVER THE FOAM BLOCK AND TIGHTEN TO HOLD THE TUBING FIRMLY IN PLACE." "CHECK PATIENT FREQUENTLY FOR SIGNS OF REDNESS, PRESSURE SORES OR IRRITATION..." "IF USING PRONGS: ENSURE THE NASAL PRONGS ARE POSITIONED AT LEAST 2MM (0.08 INCHES) FROM THE SEPTUM TO AVOID PRESSURE NECROSIS. ADJUST AS NECESSARY. THE SEPTUM MUST BE VISUALLY CHECKED FREQUENTLY ACCORDING TO HOSPITAL PROTOCOL. WE RECOMMEND HOURLY CHECKS." A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS SINCE VISITED THE HOSPITAL UPON RECEIPT OF THIS COMPLAINT AND WE UNDERSTAND THAT THE PATIENT IS IN SATISFACTORY CONDITION. WE HAVE NOT RECEIVED ANY FURTHER COMPLAINTS FROM THIS HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE STRAPS OF AN BC300 INFANT BONNET MIDLINE WERE "TOO SHORT", CAUSING THE BC180 NASAL TUBING TO PLACE PRESSURE ON THE SEPTUM OF THE NOSE. THE HOSPITAL HAS FURTHER REPORTED THAT THERE WAS "SLIGHT NECROSIS" INSIDE THE RIGHT NOSTRIL OF A PATIENT. WE UNDERSTAND THAT PATIENT'S CURRENT STATUS IS SATISFACTORY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE STRAPS OF AN BC300 INFANT BONNET MIDLINE WERE "TOO SHORT", CAUSING THE BC180 NASAL TUBING TO PLACE PRESSURE ON THE SEPTUM OF THE NOSE. THE HOSPITAL HAS FURTHER REPORTED THAT THERE WAS "SLIGHT NECROSIS" INSIDE THE RIGHT NOSTRIL OF THE PATIENT. WE UNDERSTAND THAT PATIENT'S CURRENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BONNET MIDLINE BZO BZO FISHER & PAYKEL HEALTHCARE LTD BC300-05 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 BC180 NASAL TUBING| BABYLOG 8000| BC180 NASAL TUBING| BABYLOG 8000