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2026 data FDA MAUDE openFDA FDA Class II

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.

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 MID-BOOK · MAUDE

#182 of 1000 · 13,819 reports · 1991–2026

  • BOOK 13,819 reports
  • RANK #182 of 1000
  • DEATH 360 death-typed
  • INJ 583 injury-typed
  • MALF 12,652 malfunction
  • SPAN 1991–2026
  • PEAK 2015: 2,082
  • PHOTO Catheter, Steerable

Nearest event-volume peer: Catheter, Steerable (15 report gap)

Oximeter sits #182 of 1000 among tracked device types with 13,819 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 →

Malfunction reports run above the device-type norm

Oximeter carries 91.6% MALFUNCTION-coded reports, 26.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 4.2% corpus 30.3% · below corpus mean (-26.1 pp)
  • MALF 91.6% corpus 64.8% · above corpus mean (+26.7 pp)

Lead product-problem code Incorrect Measurement is 20% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 77% of manufacturer-tagged reports · Top event location is 50% 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 13,819 MAUDE reports, ranked #182 of 1000.

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

Event Types

Malfunction 12,652 (91.6%)
Injury 583 (4.2%)
Death 360 (2.6%)
Other 158 (1.1%)
66 (0.5%)

Patient Outcomes

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

12,054 (86.7%)
Other 1,028 (7.4%)
Death 351 (2.5%)
Required Intervention 265 (1.9%)
Life Threatening 47 (0.3%)
Hospitalization 37 (0.3%)
R 31 (0.2%)
O 30 (0.2%)
L 17 (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 2,298
No Audible Alarm 1,390
Display or Visual Feedback Problem 1,093
Device Operates Differently Than Expected 825
Low Readings 745
Device Alarm System 720
High Readings 447
Device Stops Intermittently 411
Failure To Run On AC/DC 406
Sensing Intermittently 399
No Display/Image 393
Battery Problem 391
Component Missing 331
Inappropriate or Unexpected Reset 285
Unexpected Shutdown 285
Image Display Error/Artifact 258
Incorrect, Inadequate or Imprecise Result or Readings 203
Unable to Obtain Readings 198
Break 197
Device Sensing Problem 171

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: 282
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: 407
26
2026: 552

Reports in 2025 (407) held close to the prior two-year average of 469.

Related Entities for Oximeter

Top Manufacturers

PHILIPS MEDICAL SYSTEMS 1,020
COVIDIEN 301

Event Locations

6,955 (50.3%)
I 6,070 (43.9%)
HOSPITAL 512 (3.7%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Oximeter: 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 (13,819 here).

Catheter, Steerable 13,804 Excimer Laser System 13,777 Endoscope, Accessories, Narrow Band Spectrum 13,919 Single Use Only Blood Lancet With An Integr… 14,104

Similar death-typed counts

Nearest other device types by death-typed report count (360 here), distinct from the volume row.

Stents 359 Catheter, Continuous Flush 358 Artificial Heart 368 Catheter 347

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.