MR850 MR850ALURecalls & reported problems
Fisher & Paykel Healthcare Limited · Umidificatore respiratorio Potenza assorbita 220 VA Piastra di riscaldamento 150 W Filo di riscaldamento 60 W · Class 2
All models of MR850 (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09420012407245), received between Apr 5, 2022 and Oct 30, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (4 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 Alarm4
- Adverse Event Without Identified Device or Use Problem1
- Defective Alarm1
- Excessive Heating1
- No Audible Prompt/Feedback1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHILE REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20564166 ↗MalfunctionOct 30, 2024No Audible Alarm; No Audible Alarm
A DISTRIBUTOR IN CHILE REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20564165 ↗InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating
A HEALTHCARE FACILITY IN SPAIN REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT A PATIENT SUSTAINED A FACIAL BURN TO THE NOSE WHEN RECEIVING HUMIDIFIED GASES WHILE USING A NON-F&P CPAP NASAL MASK AND A MR850 RESPIRATORY HUMIDIFIER. IT WAS FURTHER REPORTED THAT THE INJURY WAS A THIRD DEGREE BURN AND REQUIRED MEDICAL TREATMENT AND SURGERY. SUBSEQUENT TO THAT, THE PATIENT'S CONDITION HAS BEEN REPORTED AS STABLE WHILE RESIDING AT HOME.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 18323768 ↗MalfunctionAug 21, 2022Defective Alarm; No Audible Alarm; Defective Alarm; No Audible Alarm
A DISTRIBUTOR IN CHILE REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15263663 ↗MalfunctionApr 5, 2022No Audible Alarm; No Audible Alarm; No Audible Prompt/Feedback
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE OF AN ISSUE WITH THE MR850 RESPIRATORY HUMIDIFIER. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS FOUND THAT THE AUDIBLE ALARM WAS NOT OPERATIONAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14008087 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- 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 Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 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.
How reports and recalls are matched · Editorial policy · Report an error on this page