MR850 MR850AGURecalls & reported problems
Fisher & Paykel Healthcare Limited · Humidifier MR850 230V DE / FR / IT EU · Class 2
All models of MR850 (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09420012407238), received between Oct 6, 2020 and Feb 17, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (9 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 Alarm9
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE AUDIBLE ALARM OF AN 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 24372163 ↗MalfunctionNov 4, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (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 23472493 ↗MalfunctionMay 25, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY 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 REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22082834 ↗MalfunctionJan 8, 2025No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY 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 21101522 ↗MalfunctionSep 24, 2023No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN FRANCE 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 17805299 ↗MalfunctionJan 5, 2023No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY 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 16110073 ↗MalfunctionJan 4, 2023No Audible Alarm; No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY 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 16098420 ↗MalfunctionAug 5, 2021No Audible Alarm
A DISTRIBUTOR IN GERMANY 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 12285216 ↗MalfunctionOct 6, 2020No Audible Alarm
A HEALTHCARE FACILITY IN GERMANY REPORTED 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 Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10639896 ↗
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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 13, 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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