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2026 data FDA MAUDE openFDA

Oximeter

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.

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FDA MAUDE casebook

openFDA event book Oximeter MID-BOOK · MAUDE

#180 of 1000 · 13,424 reports · 1991–2026

  • BOOK 13,424 reports
  • RANK #180 of 1000
  • DEATH 358 death-typed
  • INJ 570 injury-typed
  • MALF 12,273 malfunction
  • SPAN 1991–2026
  • PEAK 2015: 2,082
  • PHOTO Lens

Nearest event-volume peer: Lens, Multifocal Intraocular (200 report gap)

Oximeter sits #180 of 1000 among tracked device types with 13,424 MAUDE reports spanning 1991–2026. 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 2.7% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 4.2% corpus 30.4% · below corpus mean (-26.2 pp)
  • MALF 91.4% corpus 64.5% · above corpus mean (+26.9 pp)

Lead product-problem code Incorrect Measurement is 22% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 77% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Oximeter in the event-volume neighbourhood

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

reports

What this shows Oximeter carries 13,424 MAUDE reports, ranked #180 of 1000.

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

Event Types

Malfunction 12,273 (91.4%)
Injury 570 (4.2%)
Death 358 (2.7%)
Other 157 (1.2%)
66 (0.5%)

Patient Outcomes

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

11,699 (86.6%)
Other 1,017 (7.5%)
Death 348 (2.6%)
Required Intervention 262 (1.9%)
Life Threatening 39 (0.3%)
Hospitalization 37 (0.3%)
R 31 (0.2%)
O 28 (0.2%)
L 15 (0.1%)
S 10 (0.1%)
D 9 (0.1%)
Disability 9 (0.1%)
H 5 (0.0%)
Congenital Anomaly 4 (0.0%)

Top Product Problems

Incorrect Measurement 1,412
Display or Visual Feedback Problem 673
Low Readings 526
Device Alarm System 370
Device Operates Differently Than Expected 365
Sensing Intermittently 358
Failure To Run On AC/DC 311
Device Stops Intermittently 278
Inappropriate or Unexpected Reset 270
High Readings 258
Unexpected Shutdown 242
Image Display Error/Artifact 173
No Audible Alarm 155
Break 154
No Display/Image 148
Unable to Obtain Readings 142
Patient Device Interaction Problem 140
Incorrect, Inadequate or Imprecise Result or Readings 125
Device Sensing Problem 123
Failure to Analyze Signal 108

Yearly Trend

91
1991: 1
92
1992: 4
93
1993: 4
94
1994: 20
95
1995: 22
96
1996: 31
97
1997: 40
98
1998: 38
99
1999: 45
00
2000: 33
01
2001: 41
02
2002: 46
03
2003: 19
04
2004: 37
05
2005: 289
06
2006: 325
07
2007: 325
08
2008: 312
09
2009: 281
10
2010: 185
11
2011: 164
12
2012: 322
13
2013: 468
14
2014: 1,124
15
2015: 2,082
16
2016: 1,775
17
2017: 1,190
18
2018: 694
19
2019: 548
20
2020: 426
21
2021: 553
22
2022: 478
23
2023: 392
24
2024: 545
25
2025: 408
26
2026: 157

Related Entities for Oximeter

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 1,018
COVIDIEN 299

Event Locations

6,566 (48.9%)
I 6,070 (45.2%)
HOSPITAL 506 (3.8%)
NO INFORMATION 173 (1.3%)
HOME 37 (0.3%)
OTHER 29 (0.2%)
INVALID DATA 19 (0.1%)
UNKNOWN 11 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
NURSING HOME 3 (0.0%)
RADIOLOGY DEPARTMENT 1 (0.0%)

Compare PHILIPS MEDICAL SYSTEMS vs COVIDIEN →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Oximeter, 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 (13,424 here).

Lens, Multifocal Intraocular 13,624 Device, Vascular, For Promoting Embolization 13,654 Set, I.V. Fluid Transfer 13,718 Excimer Laser System 13,735

Similar death-typed counts

Nearest other device types by death-typed report count (358 here), distinct from the volume row.

Stents 355 Artificial Heart 364 Prosthesis 372 Catheter, Continuous Flush 342

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

Disclaimer: MAUDE figures for Oximeter 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; 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.