MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problem Fire (1245)

Patient Problem Cough (4457)

Event Date 10/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr850 respiratory humidifier and accessories have been requested to be returned to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in france reported, via a fisher & paykel healthcare (f&p) field representative, an incident in which a fire occurred when delivering high flow oxygen to a patient.An mr850 respiratory humidifier was part of the set-up involved.The fire was extinguished and the patient evacuated from the room.It was reported that following the event, the patient was coughing more frequently and blood gas tests were performed.There were no further patient consequences reported.

Event Description

A healthcare facility in france reported, via a fisher & paykel healthcare (f&p) field representative, an incident in which a fire occurred when delivering high flow oxygen to a patient.An mr850 respiratory humidifier was part of the set-up involved.The fire was extinguished and the patient evacuated from the room.It was reported that following the event, the patient was coughing more frequently and blood gas tests were performed.There were no further patient consequences reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier, together with rt380 adult evaqua2 breathing circuit, 900mr869 temperature/flow probes, 900mr805 heater wire adaptor, opt944 optiflow + adult nasal cannula and filter used at the time of the event were returned to fisher & paykel healthcare in new zealand for investigation.Fisher & paykel healthcare completed testing to replicate the device/system setup and investigate possible causes of the fire reported by the customer.This testing was based on the information provided by the customer facility on the device/system setup at the time of the reported event.Results: the chain of events, as understood by fisher & paykel healthcare, is as follows: the user connected a 900mr869 temperature probe to the mr850 respiratory humidifier with the airway probe plugged into the patient-end port of the breathing tube, however, the chamber probe was not connected to the chamber-end port of the breathing circuit.The chamber probe should be connected to the chamber-end port of the breathing circuit, however, in the reported event the chamber probe was left in ambient air.With this setup the mr850 respiratory humidifier will alarm to indicate the missing probe insertion.The user reported numerous alarms in the hours prior to the fire occurring, however, it was not possible to confirm the type of alarm condition, or the actions taken by the user to address these alarms at the time of activation.In the reported event, a second 900mr869 temperature probe was erroneously added and misconnected to the system.The humidification system is designed to only require one 900mr869 temperature probe.In the reported event, the chamber probe of a second 900mr869 temperature probe was connected to the chamber-end port of the breathing circuit and the airway probe of the second 900mr869 temperature probe was left in ambient air and not inserted into the patient-end breathing tube port.The temperature probe connector, intended to be plugged into the blue socket on the mr850 respiratory humidifier to supply power to the heater wire within the breathing circuit, was erroneously plugged into the spo2 socket of the hamilton s1 ventilator (the gas flow source at the time of the reported event).Fisher & paykel healthcare carried out a review of the sockets and keyways for the mr850 respiratory humidifier, the 900mr869 temperature probe, and the spo2 socket of the hamilton s1 ventilator.The design of the 900mr869 temperature probe socket on the mr850 respiratory humidifier and the spo2 socket on the ventilator were noted to be similar and, with force, it was possible to connect the 900mr869 temperature probe to the spo2 socket of the hamilton s1 ventilator.Fisher & paykel healthcare simulation testing identified that connecting the 900mr869 temperature probe in this manner will supply power greater than intended to the thermistor in the chamber-end temperature probe.Fisher & paykel healthcare was only able to replicate the temperature probe entering a thermal runaway condition, which is required to initiate ignition, when additional heat was applied via the gas path by continuously muting the alarm condition.Fisher & paykel healthcare was able to replicate ignition with the same device setup used by the customer, but only with higher oxygen concentrations than those reported by the customer, although this was not consistently replicated in all tests.Conclusion: other than the damage caused by the fire, there were no product defects or deformities that would have caused or contributed to the reported event.It was determined that there were multiple user errors that together contributed to the reported event.The user instructions for both the mr850 respiratory humidifier and the 900mr869 temperature probe specifically include instructions to insert the temperature probe connector into the blue socket on the humidifier.These user instructions also provide instructions for the insertion of the airway probe and chamber probe into the breathing circuit, ensuring they are correctly located and pushed into place.

• Brand Name: RESPIRATORY HUMIDIFIER
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 15764341
• MDR Text Key: 303387726
• Report Number: 9611451-2022-01015
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407221
• UDI-Public: (01)09420012407221(10)2100176506(11)170315
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2100176506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AEROGEN SOLO NEBULIZER ADAPTOR; F&P 900MR805 HEATER WIRE ADAPTOR; F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P 900MR869 TEMPERATURE/FLOW PROBE; F&P OPT944 OPTIFLOW + ADULT NASAL CANNULA; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; HAMILTON-G5 VENTILATOR; HAMILTON-S1 VENTILATOR