Temperature Probe 900MR868Recalls & reported problems
Fisher & Paykel Healthcare Limited · Sensor for MR850 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012401304), received between May 6, 2025 and Jun 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Connection Problem; Connection Problem
A DISTRIBUTOR IN PERU REPORTED THAT 39 900MR868 TEMPERATURE PROBES WERE IDENTIFIED TO HAVE A LOOSE CONNECTION WITH THE PATIENT-END TEMPERATURE PROBE PORTS OF BREATHING CIRCUITS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22199977 ↗MalfunctionMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN PERU THAT 900MR868 TEMPERATURE PROBES WERE DISLODGING FROM THE PATIENT-END TEMPERATURE PROBE PORT OF BREATHING CIRCUITS DURING SET UP AND PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973608 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.