Nellcor OXI-A/NRecalls & reported problems
Covidien LP · Adult-Neonatal SpO2 Sensor with Wraps;(1) OXI-A/N, (50) ADH-A/N · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884522042734), received between May 7, 2022 and May 19, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (4 reports).
1 other recall cover devices cleared under the same FDA submission (K012891); they may or may not involve this specific model.
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
- Temperature Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2022Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, THE UNIT CABLE STOPPED WORKING AND THE CONNECTING PORT OF THE SENSOR HAD A BURNED MARK. THERE WAS NO PATIENT INJURY. SENSOR GOT BURNED TO THE CONNECTING PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434441 ↗MalfunctionMay 7, 2022Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, THE CONNECTING PORT OF THE SENSOR HAD A BURNED MARK. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14317585 ↗MalfunctionMay 7, 2022Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, THE CONNECTING PORT OF THE SENSOR HAD A BURNED MARK. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14317355 ↗MalfunctionMay 7, 2022Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, THE CONNECTING PORT OF THE SENSOR HAD A BURNED MARK. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14317105 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.
- Z-0664-05 · Oct 18, 2004 · TerminatedNellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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