OxiMax N65PRecalls & reported problems
Covidien LP · N-65 Handheld Pulse Oximeter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521181243), received between May 28, 2019 and Jan 31, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Readings” (2 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
- Low Readings2
- Erratic or Intermittent Display1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Erratic or Intermittent Display; Low Readings; Erratic or Intermittent Display; Low Readings
ACCORDING TO THE REPORTER, DURING USE, THE UNIT DID NOT PRODUCE ACCURATE READINGS AND THE WAVE FORM WAS LOW READING. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM. THIS WAS DETERMINED DUE TO THE WAVE EITHER NOT SHOWING AT ALL OR WHEN IT WOULD PICK UP IT WOULD NOT BE ACCURATE. POWER CYCLED UNIT, REPLACED BATTERIES WITH NEW AFTER CLEANING BATTERY CONTACTS AND REPLACED NEW SENSOR TO ISOLATE THE FAILURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18613694 ↗MalfunctionAug 27, 2019Poor Quality Image; Poor Quality Image
ACCORDING TO THE REPORTER, THE UNIT HAD A SEVERAL MISSING SEGMENTS. IT WAS REPORTED THAT THE BATTERIES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8937088 ↗MalfunctionMay 28, 2019Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE UNIT HAD A LOW SPO2 READINGS AND THE NUMBERS WERE IN THE LOW 90'S. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8646052 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 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 14, 2026 · each report above links to its original FDA record
- 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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