MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BUBBLE CPAP SYSTEM; BTT

Model Number BC151-10

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The bc151-10 bubble cpap system is designed for use with spontaenously breathing infants who require cpap therapy.The following complaint devices and other components in the set-up were returned to fisher and paykel healthcare (fph) for investigation: 1x mr850 humidifier, sn:(b)(4) date of manufacture:july 15, 2008; 1x mr290 chamber, lot:130108 date of manufacture: january 08, 2013; 1x bc151 breathing circuit inspiratory limb; 1x bc151 breathing circuit expiratory limb; 1x pressure manifold; 1x 900mr868 temperature/flow probe, lot:080818 date of manufacture: august 18, 2008; 1x 70mm infant nasal tubing; 1x 900mr801 heater wire adaptor, lot:080526 date of manufacture: may 26, 2008.Method: the devices were all visually inspected.The mr850 humidifier was performance tested and further functionality tested for two days using fully functional accesories.The heater wire adaptor was performance tested.Results: the mr850 humidifier was found to have a damaged front enclosure and had a non-fph plug fitted.No heat damage was observed on the humidifier.The humidifier passed calibration and performance checks.No abnormalities were found during functionality testing.No fault was found with the humidifier; the mr290 chamber was found to have a dented aluminium base and a detatched waterfeed set.The dome of the chamber was found to be heat damaged.The breathing circuit chamber elbow was found heat damaged and still attached to one of the chamber ports; the bc151 breathing circuit inspiratory limb was found heat damaged near where the chamber elbow is located.The proximal connector was missing; the bc151 breathing circuit expiratory limb was found heat damaged.The breathing circuit had been tampered with by the user and a connector was also missing; the pressure manifold was found to be heat damaged; the temperature flow probe consists of separate chamber and patient/airway thermistors.It is inserted into the breathing circuit system to monitor temperature and flow of ventilatory gases at each end of the breathing circuit.The probe relays this information by way of electrical feedback to the humidifier.The temperature/flow probe was found to have a heat damaged chamber/flow probe.The circuit probe was found still attached to the breathing circuit; the 70mm infant nasal tubing was found to have one tube missing; no fault was found with the 900mr801 heater wire adaptor.Conclusion: information was provided by the customer stating that the breathing circuit had been reused once.The customer confirmed that the breathing circuit had been autoclaved, which would have likely damaged the single-use circuit.The most likely cause of this complaint is overheating of the heater wire due to heater wire bunching in the chamber elbow end, as a result of cleaning and reuse.Excessive heat due to bunching of the heater wire can cause the heater wire insulation to melt and allow the bare wires to touch each other causing a short circuit.This is evident in the way the chamber elbow has melted; most of the damage was sustained at the chamber elbow, where the inspiratory limb is connected.Our user instructions provide the following warnings: check the heater wire is evenly distributed along the circuit in each limb and not bunched or kinked; do not stretch or milk the tubing; do not soak, wash, sterilize or re-use this product ; this product is intended to be used for a maximum of 7 days.A letter has been sent to the hospital warning them against the reuse of our breathing circuits.

Event Description

A hospital in the (b)(6) reported that a bc151-10 bubble cpap delivery system was being used with an mr850 respiratory humidifier when a fire occurred in the system.It was reported that the baby was removed immediately when the nurse saw the smoke.The baby was given 100% o2 and was monitored.The baby was discharged three days later.No further patient consequence was reported.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5877788
• MDR Text Key: 52169149
• Report Number: 9611451-2016-00431
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC151-10
• Device Catalogue Number: BC151-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1