MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE FISHER AND PAYKEL HEALTHCARE; RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT

Model Number	MR850AEA
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) section g4: the mr850aea is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for the similar product is k110019.Method: the subject mr850 respiratory humidifier was not sent to fisher and paykel (f&p) healthcare for investigation.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the subject mr850 respiratory humidifier was not generating an audible alarm.Conclusion: without the complaint device, the root cause of the speaker fault was not determined.The mr850 respiratory humidifier product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 respiratory humidifier.In addition, the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 respiratory humidifier is equipped with visual alarm indicators in addition to the audible alarm.
Event or Problem Description
A distributor in china reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE; 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23344479
• Report Number: 9611451-2025-01104
• Device Sequence Number: 9544307
• Product Code: BTT
• UDI-Device Identifier: 09420012407177
• UDI-Public: (01)09420012407177(10)2102165034(11)220505
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: MR850AEA
• Device Catalogue Number: MR850AEA
• Device Lot Number: 2102165034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown