MR850 MR850JHURecalls & 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 18, 2026 from official FDA records · Editorial policy
Quick summary
This Fisher & Paykel MR850 respiratory humidifier is used to add moisture to breathing gases. The 93 reports mostly describe alarms or speakers not working, with 92 reported malfunctions, no deaths, and 1 injury. No recalls name this device; reports fell from 21 in the previous 12 months to 12 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 09420012407290), received between Feb 3, 2018 and Sep 28, 2026 — classified as 1 injury, 92 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (62 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm62
- Mechanical Problem15
- Device Alarm System6
- Defective Alarm5
- Break3
- Fire2
- Low Audible Alarm2
- Therapeutic or Diagnostic Output Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions89
- Insufficient Information1
- Low Oxygen Saturation1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910518 ↗MalfunctionSep 24, 2026No Audible Alarm
A healthcare facility in California reported that the audible alarm of an MR850 Respiratory Humidifier was not functioning. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877283 ↗MalfunctionJul 1, 2026Fire
A healthcare facility in (b)(6) reported an event involving an MR850 Respiratory Humidifier and RT380 Adult Ventilator Circuit, used with a ventilator with nebuliser. It was reported that a patient was receiving therapy with an MR850 Respiratory Humidifier and RT380 Adult Ventilator Circuit when the respiratory humidifier generated an alarm(s). The healthcare facility reported that staff responded by replacing the humidifier, as well as the water chamber, heater wire adaptor, and temperature probe. A "glowing red visual" was then noted at the replacement humidification chamber. Flames were subsequently observed and staff responded.The healthcare facility subsequently reported that the subject device and breathing circuit was being used in conjunction with a Hamilton G5 Ventilator, wall oxygen, an Aerogen Nebuliser, bacterial filters and carbon dioxide monitoring.The healthcare facility has not reported any patient or user harm in relation to this event to F&P Healthcare.
Patient problems: Insufficient Information
MAUDE report 25674369 ↗MalfunctionJun 24, 2026No Audible Alarm
DURING DEVICE EVALUATION OF A MR850 RESPIRATORY HUMIDIFIER AT OUR FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN THE USA, IT WAS FOUND THAT THE SPEAKER WAS NON-OPERATIONAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25616666 ↗MalfunctionMay 25, 2026No Audible Alarm
DURING DEVICE SERVICE OF AN MR850 RESPIRATORY HUMIDIFIER AT OUR FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN THE UNITED STATES OF AMERICA, IT WAS FOUND THAT THE DEVICE SPEAKER WAS NON-OPERATIONAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273144 ↗MalfunctionMay 14, 2026No Audible Alarm
DURING DEVICE EVALUATION OF AN MR850 RESPIRATORY HUMIDIFIER AT OUR FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN THE USA, IT WAS FOUND THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167900 ↗MalfunctionMay 6, 2026Defective Alarm
DURING DEVICE EVALUATION OF A MR850 RESPIRATORY HUMIDIFIER AT OUR FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN USA, IT WAS FOUND THAT THE AUDIBLE ALARM WAS DISTORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107180 ↗MalfunctionApr 7, 2026No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN NEVADA THAT THE AUDIBLE ALARM OF TWO MR850 RESPIRATORY HUMIDIFIERS WERE NOT FUNCTIONING. THIS WAS IDENTIFIED DURING MAINTENANCE TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24812164 ↗MalfunctionMar 12, 2026No Audible Alarm
DURING DEVICE EVALUATION OF AN MR850 RESPIRATORY HUMIDIFIER AT OUR FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN THE UNITED STATES OF AMERICA, IT WAS FOUND THAT THE SPEAKER WAS NON-OPERATIONAL. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586623 ↗MalfunctionJan 26, 2026Low Audible Alarm
DURING DEVICE EVALUATION OF A MR850 RESPIRATORY HUMIDIFIER AT OUR FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL OFFICE IN THE U.S, IT WAS FOUND THAT THE SPEAKER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185904 ↗MalfunctionJan 20, 2026No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24126507 ↗MalfunctionNov 13, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN KANSAS REPORTED A FAULT WITH AN MR850 RESPIRATORY HUMIDIFIER. DURING SERVICE, IT WAS IDENTIFIED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550393 ↗MalfunctionOct 30, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433285 ↗MalfunctionOct 20, 2025Device Alarm System; Device Alarm System
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER WAS DAMAGED. UPON SERVICING AT THE FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL SERVICE CENTRE, IT WAS FOUND THAT THE AUDIBLE SPEAKER WAS FAULTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23344403 ↗MalfunctionOct 19, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER WAS DAMAGED. UPON SERVICING AT THE FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL SERVICE CENTRE, IT WAS FOUND THAT THE AUDIBLE SPEAKER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334095 ↗MalfunctionOct 15, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) 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 23297809 ↗MalfunctionSep 30, 2025Mechanical Problem; Mechanical Problem
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE POWER CORD OF AN MR850JHU RESPIRATORY HUMIDIFIER WAS DAMAGED WITH EXPOSED WIRES. THERE WAS NO PATIENT OR USER HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23187587 ↗MalfunctionSep 28, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED A FAULT WITH A MR850 RESPIRATORY HUMIDIFIER. DURING SERVICING IT WAS FOUND THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23164064 ↗MalfunctionSep 7, 2025Mechanical Problem; Mechanical Problem
A HEALTHCARE FACILITY IN FLORIDA REPORTED THAT THE POWER CORD OF AN MR850JHU RESPIRATORY HUMIDIFIER WAS FOUND DAMAGED. THE HEALTHCARE FACILITY CONFIRMED THAT THE DAMAGE HAD EXPOSED THE POWER CORD'S CONDUCTIVE WIRES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989626 ↗MalfunctionAug 26, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN CALIFORNIA 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 22900755 ↗MalfunctionAug 26, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN NEW YORK 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 22891966 ↗MalfunctionAug 19, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846838 ↗MalfunctionJul 6, 2025Low Audible Alarm; Low Audible Alarm
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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 22409101 ↗MalfunctionJul 2, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN INDIANA 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 22391657 ↗MalfunctionMay 21, 2025Device Alarm System; Device Alarm System
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER WAS FAULTY. DURING SERVICING AT THE FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL SERVICE CENTRE, IT WAS FOUND THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS FAULTY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066862 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 reports
- F&P Optiflow Junior 2 OJR414Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)56 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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