MR850Recalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 164
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls
- 0
We found 10 models of MR850 by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 164 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2017 and Sep 28, 2026 — classified as 1 death, 3 injuries, 160 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (125 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MR850 problems
Device problems
- No Audible Alarm125
- Mechanical Problem16
- Defective Alarm9
- Device Alarm System9
- Fire4
- Break3
- No Audible Prompt/Feedback3
- Therapeutic or Diagnostic Output Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- No Patient Involvement3
- Low Oxygen Saturation2
- Cough1
- Death1
- Full thickness (Third Degree) Burn1
- Insufficient Information1
- No Consequences Or Impact To Patient1
MR850 models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MR850 MR850JHUHumidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- MR850 MR850AEAHumidifier, Respiratory Gas, (Direct Patient Interface)19 reports
- MR850 MR850AEKHumidifier, Respiratory Gas, (Direct Patient Interface)14 reports
- MR850 MR850AFUHumidifier, Respiratory Gas, (Direct Patient Interface)13 reports
- MR850 MR850AGUHumidifier, Respiratory Gas, (Direct Patient Interface)9 reports
- MR850 MR850AEUHumidifier, Respiratory Gas, (Direct Patient Interface)1 death7 reports
- MR850 MR850ALUHumidifier, Respiratory Gas, (Direct Patient Interface)5 reports
- MR850 MR850JSUHumidifier, Respiratory Gas, (Direct Patient Interface)2 reports
- MR850 MR850ANUHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
- MR850 MR850ARUHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
Recent MR850 adverse event reports
The 15 most recent reports across all models, 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 20, 2026No Audible Alarm
A DISTRIBUTOR IN SINGAPORE REPORTED VIA A FISHER & PAYKEL (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 25234135 ↗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 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 ↗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 ↗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 ↗MalfunctionFeb 26, 2026Defective Alarm
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED 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 24464779 ↗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 ↗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 ↗
Other Fisher & Paykel Healthcare Limited products
All Fisher & Paykel Healthcare Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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