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

Model Number MR850

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

A healthcare facility in spain reported via a fisher & paykel healthcare (f&p) field representative, that a neonate sustained a third degree burn to the nose when receiving humidification from a f&p healthcare mr850 respiratory humidifier via a f&p healthcare rt265 infant evaqua2 breathing circuit and a nasal mask manufacturered by a third party.It was also reported that the patient required additional medical treatment and surgery as a result of the injury.There were no further patient consequences reported.

Manufacturer Narrative

(b)(4).The complaint mr850 respiratory humidifier is currently en route to fisher & paykel (f&p) healthcare for evaluation to determine the involvement of our product in the reported event.We will provide a follow-up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Corected data: d4 - serial number and udi (unique device identifier).D9 - device returned to manufacturer - date of return.H6 - health effect - impact code.- medical device problem code.Method: the subject mr850 respiratory humidifier (sn (b)(6), the 900mr805 heater wire adaptor (lot 2101452494) and the 900mr869 temperature/flow probe (lot 140407) in use during the reported event were returned to the fisher & paykel (f&p) healthcare in new zealand where they were visually inspected and functionally tested.Our investigation is based on the information provided by the healthcare facility, f&p healthcare's evaluation of the returned devices, and our knowledge of the products.Results: visual inspection of the mr850 respiratory humidifier identified some minor damage to the enclosure of the mr850 respiratory humidifier.There were no defects or damage observed on the 900mr805 heater wire adaptor or the 900mr869 temperature/flow probe.The mr850 respiratory humidifier and the 900mr869 temperature/flow probe passed functional testing, including the alarm system check.Other than the enclosure damage, no faults or malfunctions were identified with either device.During the functional testing of the 900mr805 heater wire adaptor, an intermittent heater wire alarm occurred during the startup of the subject mr850 respiratory humidifier.Further testing of the 900mr805 heater wire adaptor confirmed an intermittent continuity between one of the heater wire connector pins and its wire.The intermittent connection of the 900mr805 heater wire adaptor would not cause or contribute to the reported elevated temperature on the mr850 respiratory humidifier.A faulty heater wire adaptor would generate an alarm condition on the mr850 respiratory humidifier, and the humidifier will immediately turn off power to the heater wires and heater plate.The healthcare facility did not confirm that any alarm conditions occurred at the time of the reported event.Conclusion: based on the information provided by the healthcare facility and the investigation we have undertaken we have been unable to determine the cause of the reported temperature fluctuation on the mr850 respiratory humidifier or the injury sustained by the patient.The subject mr850 respiratory humidifier and the 900mr869 temperature/flow probe were confirmed to be operating as intended and within specification.The mr850 respiratory humidifier is used to warm and humidify gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or medical gases.The mr850 complies with iso8185:2007: "respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems." this standard specifies safety requirements to prevent the risk of thermal injury, including maximum enthalpy limits for humidified gas delivered to patients through respiratory humidification systems.The mr850 respiratory humidifier features an audible and visual alarm which alerts the user if the displayed temperature exceeds 41°c, or if the airway temperature exceeds 43°c and immediately disables the heater wire and the heater-plate.The mr850 respiratory humidifier user instruction states the following warning: ensure that both temperature probe sensors are correctly and securely fitted.Failure to do so may result in temperatures in excess of 41°c being delivered to the patient.The rt265 infant evaqua2 breathing circuit user instruction also states the following warnings: do not use heated wire breathing circuits without gas flow.If gas flow is interrupted, turn the humidifier off.Avoid prolonged contact of heated tubes with patient's skin.Check all connections are tight before use.

Event Description

A healthcare facility in spain reported via a fisher & paykel (f&p) healthcare field representative, that a patient sustained a facial burn to the nose when receiving humidified gases while using a non-f&p cpap nasal mask and a mr850 respiratory humidifier.It was further reported that the injury was a third degree burn and required medical treatment and surgery.Subsequent to that, the patient's condition has been reported as stable while residing at home.

• 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: 18323768
• MDR Text Key: 330428100
• Report Number: 9611451-2023-01126
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407245
• UDI-Public: (01)09420012407245
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 120403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2012
• 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: F&P 900MR805 HEATER WIRE ADAPTOR.; F&P 900MR869 TEMPERATURE/FLOW PROBE.; F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT.; F&P RT265 INFANT EVAQUA2 BREATHING CIRCUIT.; GETINGE® SERVO -N VENTILATOR.; GETINGE® SERVO -N VENTILATOR.; HAMILTON MEDICAL® 281976 NCPAP GENERATOR.; HAMILTON MEDICAL® 281976 NCPAP GENERATOR.; HAMILTON MEDICAL® MEDIN NASAL MASK.; HAMILTON MEDICAL® MEDIN NASAL MASK.
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Sex: Male