MR850 MR850AFURecalls & reported problems
Fisher & Paykel Healthcare Limited · Humidificateur respiratoire Alimentation 220 VA Plaque chauffante 150 W Fil chauffant 60 W · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 09420012407221), received between Jul 28, 2021 and Mar 9, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (11 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm11
- Fire1
- No Audible Prompt/Feedback1
- Pressure Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Cough1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE AUDIBLE ALARM OF THE MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THIS WAS IDENTIFIED DURING MAINTENANCE ACTIVITIES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24554147 ↗MalfunctionMar 27, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REQUESTED A SERVICE FOR AN MR850 RESPIRATORY HUMIDIFIER. UPON RECEIPT AT THE FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL SERVICE CENTRE, IT WAS DISCOVERED 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 21715730 ↗MalfunctionOct 6, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20380235 ↗MalfunctionSep 9, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE 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 20177507 ↗MalfunctionAug 15, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS FAULTY. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19997647 ↗MalfunctionJul 17, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS FAULTY. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19758081 ↗MalfunctionJun 21, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT A MR850 RESPIRATORY HUMIDIFIER WAS FOUND WITH A FAULTY SPEAKER. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581745 ↗MalfunctionJun 21, 2024No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT A MR850 RESPIRATORY HUMIDIFIER WAS FOUND WITH A FAULTY SPEAKER. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580701 ↗MalfunctionOct 26, 2023Pressure Problem; Pressure Problem
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE MANOMETER OF AN RD900 NEOPUFF INFANT RESUSCITATOR WAS DAMAGED. 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 18017244 ↗MalfunctionDec 1, 2022No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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 15891676 ↗MalfunctionNov 9, 2022Fire; Fire
A HEALTHCARE FACILITY IN FRANCE REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, AN INCIDENT IN WHICH A FIRE OCCURRED WHEN DELIVERING HIGH FLOW OXYGEN TO A PATIENT. AN MR850 RESPIRATORY HUMIDIFIER WAS PART OF THE SET-UP INVOLVED. THE FIRE WAS EXTINGUISHED AND THE PATIENT EVACUATED FROM THE ROOM. IT WAS REPORTED THAT FOLLOWING THE EVENT, THE PATIENT WAS COUGHING MORE FREQUENTLY AND BLOOD GAS TESTS WERE PERFORMED. THERE WERE NO FURTHER PATIENT CONSEQUENCES REPORTED.
Patient problems: Cough
MAUDE report 15764341 ↗MalfunctionJun 13, 2022No Audible Alarm; No Audible Alarm; No Audible Prompt/Feedback
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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 14681910 ↗MalfunctionJul 28, 2021No Audible Alarm; Therapeutic or Diagnostic Output Failure; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, 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 12236113 ↗
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 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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