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

Model Number	MR850AEK
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).Method: the subject mr850 respiratory humidifier was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the video and description of events provided by the distributor, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided video observed that audible alarms of the mr850 respiratory humidifier was not functioning.Conclusion: f&p healthcare's investigation was unable to determine the root cause of the reported issue.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 singapore reported via a fisher & paykel (f&p) field representative that the audible alarm of an mr850 respiratory humidifier was not functioning.There was no reported patient involvement.

• Brand Name: MR850
• Common Device Name: RESPIRATORY HUMIDIFIER
• 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: 25234135
• Report Number: 9611451-2026-01708
• Device Sequence Number: 18714551
• Product Code: BTT
• UDI-Device Identifier: 09420012407184
• UDI-Public: (01)09420012407184(10)2101414309(11)201201
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Other
• Device Model Number: MR850AEK
• Device Catalogue Number: MR850AEK
• Device Lot Number: 2101414309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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