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MR850 MR850ANURecalls & reported problems

Fisher & Paykel Healthcare Limited · Respiratory Humidifier MR850 230V NO/SW/FI · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012407252), received between Dec 7, 2020 and Dec 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Audible Alarm” (1 report).

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.

Most reported problems

Device problems

  • No Audible Alarm1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 7, 2020No Audible Alarm; No Audible Alarm

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE MR850 RESPIRATORY HUMIDIFIER WAS NOT WORKING PROPERLY. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN (B)(6), THE SPEAKER WAS FOUND TO BE FAULTY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10963151 ↗

Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices

All Humidifier, Respiratory Gas, (Direct Patient Interface) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.