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2026 data FDA MAUDE openFDA

Oximeter, Tissue Saturation

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

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FDA MAUDE casebook

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

#767 of 1000 · 685 reports · 2004–2026

  • BOOK 685 reports
  • RANK #767 of 1000
  • DEATH 6 death-typed
  • INJ 55 injury-typed
  • MALF 612 malfunction
  • SPAN 2004–2026
  • PEAK 2024: 140
  • PHOTO Endoscopic Cytology B…

Nearest event-volume peer: Endoscopic Cytology Brush (1 report gap)

Oximeter, Tissue Saturation sits #767 of 1000 among tracked device types with 685 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 8.0% corpus 30.4% · below corpus mean (-22.4 pp)
  • MALF 89.3% corpus 64.5% · above corpus mean (+24.8 pp)

Lead product-problem code Low Readings is 20% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 51% of manufacturer-tagged reports · Top event location is 70% 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 685 MAUDE reports, ranked #767 of 1000.

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

Event Types

Malfunction 612 (89.3%)
Injury 55 (8.0%)
Other 10 (1.5%)
Death 6 (0.9%)
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.

581 (84.0%)
Other 76 (11.0%)
Required Intervention 18 (2.6%)
Death 6 (0.9%)
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 170
Incorrect Measurement 107
Incorrect, Inadequate or Imprecise Result or Readings 101
Failure to Analyze Signal 68
Patient Device Interaction Problem 51
High Readings 47
Communication or Transmission Problem 45
Manufacturing, Packaging or Shipping Problem 40
Erratic or Intermittent Display 39
Defective Device 30
Image Display Error/Artifact 28
Device Alarm System 26
Adverse Event Without Identified Device or Use Problem 20
Patient-Device Incompatibility 15
Contamination /Decontamination Problem 14
Use of Device Problem 12
Insufficient Information 11
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: 4

Related Entities for Oximeter, Tissue Saturation

Top Manufacturers

EDWARDS LIFESCIENCES 101
MMJ SA DE CV (USD) 86
MEDTRONIC NEUROMODULATION 11

Event Locations

479 (69.9%)
I 176 (25.7%)
HOSPITAL 29 (4.2%)
NO INFORMATION 1 (0.1%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Oximeter, Tissue Saturation, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (685 here).

Endoscopic Cytology Brush 686 Subsystem, Water Purification 686 Radioimmunoassay, Estradiol 689 Osteotome 680

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 Device, Percutaneous Retrieval 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.