MR850 MR850AEARecalls & 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
- 19
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 09420012407177), received between Sep 9, 2020 and Mar 30, 2026 — classified as 1 injury, 18 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (18 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
Most reported problems
Device problems
- No Audible Alarm18
- Insufficient Device Problem Information1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Low Oxygen Saturation1
- No Patient Involvement1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735057 ↗MalfunctionFeb 10, 2026No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24310500 ↗MalfunctionFeb 10, 2026No Audible Alarm
A DISTRIBUTOR IN CHINA REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24310496 ↗MalfunctionJan 26, 2026No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE SPEAKER OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185496 ↗MalfunctionNov 18, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY 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 23586247 ↗MalfunctionNov 4, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA 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 23472698 ↗MalfunctionOct 20, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA 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 23344479 ↗MalfunctionSep 28, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY 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 23164009 ↗MalfunctionSep 11, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23034313 ↗MalfunctionJul 29, 2025No Audible Alarm; No Audible Alarm
A DISTRIBUTOR ON BEHALF OF A HEALTHCARE FACILITY IN CHINA 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 22652675 ↗MalfunctionDec 6, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE SPEAKER OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20859837 ↗MalfunctionDec 5, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE SPEAKER OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20859036 ↗MalfunctionOct 6, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA REPORTED 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 20380234 ↗MalfunctionSep 29, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20330479 ↗MalfunctionSep 16, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA REPORTED 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 20233881 ↗MalfunctionAug 13, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHINA 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 19978602 ↗MalfunctionJul 18, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA 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 19779988 ↗InjuryJul 4, 2024Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information
A HEALTHCARE FACILITY IN CHINA REPORTED, VIA THE NMPA REPORTING SYSTEM, THAT A VENTILATED PATIENT DESATURATED TO 60% SPO2 AND BECAME CYANOTIC WHILE RECEIVING HUMIDIFICATION VIA AN MR850 RESPIRATORY HUMIDIFIER. THE PATIENT WAS RE-INTUBATED AND IT WAS IDENTIFIED THAT THERE WAS MUCUS PLUG BLOCKING THE ENDOTRACHEAL TUBE. THE HEALTHCARE FACILITY ALSO REPORTED THAT AFTER CHANGING THE ENDOTRACHEAL TUBE, THE PATIENT'S OXYGEN SATURATION AND VITAL SIGNS RETURNED TO NORMAL.
Patient problems: Low Oxygen Saturation
MAUDE report 19672971 ↗MalfunctionSep 9, 2020No Audible Alarm; No Audible Alarm
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6), VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HEATED HUMIDIFIER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10505992 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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