MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MR850; RESPIRATORY HUMIDIFIER

Model Number	MR850AFU
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject mr850 respiratory humidifier has been requested to be returned to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in france reported that the audible alarm of the mr850 respiratory humidifier was not functioning.This was identified during maintenance activities.There was no patient involvement.

• Brand Name: MR850
• Common Device Name: RESPIRATORY HUMIDIFIER
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 24554147
• Report Number: 9611451-2026-00866
• Device Sequence Number: 9466520
• Product Code: BTT
• UDI-Device Identifier: 09420012407221
• UDI-Public: (01)09420012407221(10)2101215840(11)200724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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 Model Number: MR850AFU
• Device Catalogue Number: MR850AFU
• Device Lot Number: 2101215840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• 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