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2026 data FDA MAUDE openFDA FDA Class II

Oximeter, Tissue Saturation

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.2700 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Oximeter, Tissue Saturation LIGHT-BOOK · MAUDE

#773 of 1000 · 706 reports · 2004–2026

  • BOOK 706 reports
  • RANK #773 of 1000
  • DEATH 6 death-typed
  • INJ 55 injury-typed
  • MALF 633 malfunction
  • SPAN 2004–2026
  • PEAK 2024: 140
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Elbow, Semi-Constrained, Cemented (2 report gap)

Oximeter, Tissue Saturation sits #773 of 1000 among tracked device types with 706 MAUDE reports spanning 2004–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Oximeter, Tissue Saturation carries 89.7% MALFUNCTION-coded reports, 24.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 7.8% corpus 30.3% · below corpus mean (-22.5 pp)
  • MALF 89.7% corpus 64.8% · above corpus mean (+24.8 pp)

Lead product-problem code Low Readings is 19% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 52% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Oximeter, Tissue Saturation in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Oximeter, Tissue Saturation carries 706 MAUDE reports, ranked #773 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 633 (89.7%)
Injury 55 (7.8%)
Other 10 (1.4%)
Death 6 (0.8%)
1 (0.1%)
No answer provided 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

600 (84.3%)
Other 77 (10.8%)
Required Intervention 18 (2.5%)
Death 6 (0.8%)
O 3 (0.4%)
Hospitalization 2 (0.3%)
D 1 (0.1%)
L 1 (0.1%)
R 1 (0.1%)
S 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Low Readings 174
Incorrect Measurement 113
Incorrect, Inadequate or Imprecise Result or Readings 105
Failure to Analyze Signal 69
High Readings 52
Patient Device Interaction Problem 52
Communication or Transmission Problem 45
Manufacturing, Packaging or Shipping Problem 40
Erratic or Intermittent Display 39
Device Alarm System 33
Defective Device 30
Image Display Error/Artifact 28
Insufficient Device Problem Information 24
Adverse Event Without Identified Device or Use Problem 21
Patient-Device Incompatibility 15
Contamination /Decontamination Problem 14
Use of Device Problem 13
Temperature Problem 10
Sensing Intermittently 9
Device Damaged Prior to Use 8

Yearly Trend

04
2004: 1
08
2008: 2
09
2009: 7
10
2010: 1
11
2011: 2
12
2012: 3
13
2013: 8
14
2014: 4
16
2016: 9
17
2017: 24
18
2018: 38
19
2019: 107
20
2020: 50
21
2021: 27
22
2022: 52
23
2023: 73
24
2024: 140
25
2025: 133
26
2026: 25

Reports in 2025 (133) held close to the prior two-year average of 107.

Related Entities for Oximeter, Tissue Saturation

Top Manufacturers

EDWARDS LIFESCIENCES 105
MMJ SA DE CV (USD) 86
MEDTRONIC NEUROMODULATION 11

Event Locations

499 (70.7%)
I 176 (24.9%)
HOSPITAL 30 (4.2%)
NO INFORMATION 1 (0.1%)

Compare EDWARDS LIFESCIENCES vs MMJ SA DE CV (USD) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Oximeter, Tissue Saturation: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (706 here).

Prosthesis 704 Resin, Root Canal Filling 703 Coronary Covered Stent 702 Lectins And Protectins 701

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Oximeter, Tissue Saturation are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Oximeter, Tissue Saturation; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.