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

Model Number MR850

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2023

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 distributor in india reported, via a fisher & paykel (f&p) healthcare field representative, an incident in which a fire occurred when setting up a bubble cpap system.An mr850 respiratory humidifier was part of the set-up and was being used with a f&p healthcare temperature probe and a non f&p healthcare heaterwire adaptor (manufacturer unknown).The user facility reported to f&p healthcare that the bubble cpap system was set up and connected to oxygen at 5l/min in preparation for patient use.Within approximately 10 minutes of initial set-up the device was observed to be on fire.It was also reported that the bc161 bubble cpap system had been in patient use for approximately one year.There was no patient involvement or injuries reported as a result of this event.The complaint device and accessories have been requested to be returned to f&p healthcare for further analysis.

Event Description

A distributor in india reported, via a fisher & paykel (f&p) healthcare field representative, an incident in which a fire occurred when setting up a bubble cpap system.The healthcare facility reported to f&p healthcare that the bubble cpap system was being set up in preparation for patient use however the devices were not in use on a patient nor connected to a patient at the time of the reported event.The system included an f&p healthcare mr850 respiratory humidifier that was being used with a f&p healthcare temperature probe and a non-f&p healthcare heaterwire adaptor (manufacturer unknown).The healthcare facility also reported that the f&p healthcare bc161 bubble cpap system had been re-used for approximately one year and had been used on multiple patients during this time.The healthcare facility reported that, following set up of the devices and prior to patient use, the mr850 respiratory humidifier was powered on and heating, and the oxygen was connected with a flow rate of 5l/min.Within approximately 10 minutes the humidification chamber, which is provided as part of the bc161 bubble cpap system, was observed to be on fire.There was no patient involvement or user injuries reported as a result of this event.

Manufacturer Narrative

(b)(4).Method: the subject mr850 respiratory humidifier and associated devices were requested for evaluation however no products were returned to fisher & paykel healthcare for analysis.Our investigation is therefore based on the information, photographs and video provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that a fire occurred when setting up a bubble cpap system.The devices were not in use on a patient nor connected to a patient at the time of the reported event.The healthcare facility reported that, following set up of the devices, the mr850 respiratory humidifier was powered on and heating, and the oxygen was connected with a flow rate of 5l/min.Within approximately 10 minutes the humidification chamber, which is provided as part of the cb161 bubble cpap system, was observed to be on fire.The healthcare facility also reported that the f&p healthcare bc161 bubble cpap system had been re-used for approximately one year and had been used on multiple patients during this time.Review of the video file provided by the healthcare facility confirmed that the devices were not connected to a patient when the fire occurred.The video file shows the humidification chamber fitted to the mr850 respiratory humidifier is on fire.The hospital staff are seen extinguishing the fire.There are multiple electrical cables visible on the floor in the location of the bubble cpap system devices.Other medical devices, including an infant warmer and a syringe pump, are also visible in close proximity.The photographs provided confirm that the heaterwire adaptor in use at the time of the reported event was not manufactured by f&p healthcare.The heaterwire adaptor provides electrical power from the respiratory humidifier to the inspiratory and expiratory circuit limbs.Review of the photographs and the video showed evidence of fire damage to the re-used humidification chamber dome (melted), temperature probe, non-f&p healthcare heater wire adaptor and part of the inspiratory circuit.Conclusion: without the return of the subject device, we are unable to determine what may have caused the reported fire.The healthcare facility confirmed that a non-approved heaterwire adaptor was being used at the time of the fire.Additionally, the healthcare facility reported that the single-use bc161 bubble cpap system (including the heated wire breathing circuits) had been in use for approximately one year and used on multiple patients during this time.The user instructions for the mr850 state the following: "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance and compromise safety." "remove any sources of ignition, such as cigarettes, an open flame, or materials which burn or ignite easily at high oxygen concentrations." the user instructions for the bc161 state the following: "all components of the bubble cpap system are single use only." "do not reuse any part of the bc161.It is manufactured for single patient use only.Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." "this product is intended to be used for a maximum of 7 days." "remove any sources of ignition, such as cigarettes or open flames." "do not add or modify any attachments or accessories to the humidifier that are not specified or approved for use with the humidifier or accessory, or the humidifier might not function correctly, affecting the quality of the therapy or injuring the patient." "the responsible organization is accountable for the compatibility of the humidifier and all of the parts and accessories used to connect to the patient and other equipment before use." "do not soak, wash, sterilize or reuse this product.Avoid contact with non-approved chemicals".

• 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: 18089290
• MDR Text Key: 327585832
• Report Number: 9611451-2023-00962
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407207
• UDI-Public: (01)09420012407207(10)2101581704(11)210331
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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: 2101581704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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: BIOMED BLENDER; BIOMED BLENDER; F&P BC161 BUBBLE CPAP SYSTEM; F&P BC161 BUBBLE CPAP SYSTEM; F&P BC191 FLEXITRUNK NASAL CPAP INTERFACE; F&P BC191 FLEXITRUNK NASAL CPAP INTERFACE; F&P TEMPARATURE PROBE; F&P TEMPARATURE PROBE; NON-F&P HEATERWIRE ADAPTER; NON-F&P HEATERWIRE ADAPTER