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

Model Number MR850

Device Problem Excessive Heating (4030)

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

Event Type  Injury  

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative, that a patient experienced a third degree burn to the nose, cheek and neck when using bc151-10 bubble cpap interface and mr850 respiratory humidifier.It was further reported by the hospital that the temperature probe which measures the gas temperature and flow had not been plugged-in as intended.The customer also reported that an alarm was triggered and that this was not actioned by the hospital staff.

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 australia reported via a fisher & paykel healthcare (f&p) field representative, that a patient experienced a third degree burn to the nose, cheek and neck when using bc151-10 bubble cpap interface and mr850 respiratory humidifier.It was further reported by the hospital that the temperature probe which measures the gas temperature and flow had not been plugged-in as intended.The customer also reported that an alarm was triggered and that this was not actioned by the hospital staff.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is therefore based on the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility reported that a neonate experienced a third degree burn to the nose, cheek and neck when using bc151-10 bubble cpap interface and mr850 respiratory humidifier.The healthcare facility completed an internal investigation and have advised f&p healthcare that the likely cause of the reported event was user error due to the temperature probe not being plugged into the mr290 humidification chamber.This user error would result in a mr850 respiratory humidifier alarm condition.The healthcare facility confirmed that an alarm was triggered but this was not actioned by the user.The healthcare facility also advised that no faults were identified with the f&p healthcare devices.Conclusion: based on the information provided by the healthcare facility, the reported event was most likely a result of user error.The user instructions that accompany the mr850 respiratory humidifier state "ensure that both temperature probe sensors are correctly and securely fitted.Failure to do so may result in gas temperatures in excess of 41°c being delivered to the patient." additionally, the user instructions provide visual and written instructions for setting up the humidifier, including correct placement of the temperature probe.The user instructions also advise the user that a chamber probe alarm indicates that the chamber probe is not inserted into the breathing circuit.

• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine 92618 ; 9494534000
• MDR Report Key: 16009550
• MDR Text Key: 305751448
• Report Number: 9611451-2022-01177
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 BC151-10 BUBBLE CPAP INTERFACE.; F&P BC151-10 BUBBLE CPAP INTERFACE.
• Patient Outcome(s): Required Intervention