MR850 MR850AEKRecalls & reported problems

Fisher & Paykel Healthcare Limited · Heated respiratory humidifier Power input 220 VA Heater plate 150 W Heater wire 60 W · Class 2

All models of MR850 (10)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 14
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 09420012407184), received between Jun 1, 2017 and May 20, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Audible Alarm13
Defective Alarm2
Device Alarm System2
No Audible Prompt/Feedback1
Output Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions13
No Patient Involvement1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 20, 2026No Audible Alarm
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234135 ↗
MalfunctionFeb 26, 2026Defective Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS DISTORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24464779 ↗
MalfunctionJul 21, 2025Defective Alarm; No Audible Alarm; Defective Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22562053 ↗
MalfunctionJun 25, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SPEAKER OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19611535 ↗
MalfunctionMay 8, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SPEAKER OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19273688 ↗
MalfunctionDec 19, 2023No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18361417 ↗
MalfunctionFeb 14, 2023No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16375583 ↗
MalfunctionAug 18, 2022No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED AN ISSUE WITH AN MR850 RESPIRATORY HUMIDIFIER. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN ENGLAND, IT WAS DISCOVERED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15255382 ↗
MalfunctionMay 4, 2022No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS FOUND TO NOT BE FUNCTIONING DURING A ROUTINE PREVENTATIVE MAINTENANCE CHECK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14283854 ↗
MalfunctionApr 4, 2022No Audible Alarm; No Audible Alarm; Output Problem
A DISTRIBUTOR IN (B)(4) REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13992804 ↗
MalfunctionNov 22, 2021Device Alarm System; No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12857474 ↗
MalfunctionJun 3, 2021No Audible Alarm; Device Alarm System; No Audible Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11935046 ↗
MalfunctionJan 14, 2021No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6)THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HEATED HUMIDIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11173144 ↗
MalfunctionJun 1, 2017No Audible Alarm; No Audible Alarm
A HOSPITAL IN THE (B)(6) REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER HAD FAILED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6606321 ↗

Device details

UDI-DI	`09420012407184`
Brand	MR850
Model	MR850AEK
Company	Fisher & Paykel Healthcare Limited
Product code	BTT · Humidifier, Respiratory Gas, (Direct Patient Interface)
Class	Class 2
FDA submission	K110019
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 10, 2026

Device type (GMDN): Heated respiratory humidifier

A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

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All Humidifier, Respiratory Gas, (Direct Patient Interface) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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