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2026 data FDA MAUDE openFDA FDA Class II

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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 §862.1120 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Electrode Measurement LIGHT-BOOK · MAUDE

#456 of 1000 · 2,392 reports · 1996–2026

  • BOOK 2,392 reports
  • RANK #456 of 1000
  • DEATH 46 death-typed
  • INJ 69 injury-typed
  • MALF 2,109 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 212
  • PHOTO Transducer

Nearest event-volume peer: Transducer, Pressure, Catheter Tip (3 report gap)

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph sits #456 of 1000 among tracked device types with 2,392 MAUDE reports spanning 1996–2026. 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 →

Injury-coded reports sit below the device-type norm

Electrode Measurement carries 2.9% INJURY-coded reports, 27.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 2.9% corpus 30.3% · below corpus mean (-27.4 pp)
  • MALF 88.2% corpus 64.8% · above corpus mean (+23.3 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 19% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 53% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Electrode Measurement in the event-volume neighbourhood

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

reports

What this shows Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph carries 2,392 MAUDE reports, ranked #456 of 1000.

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

Event Types

Malfunction 2,109 (88.2%)
Other 97 (4.1%)
71 (3.0%)
Injury 69 (2.9%)
Death 46 (1.9%)

Patient Outcomes

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

2,147 (89.5%)
Other 146 (6.1%)
Death 43 (1.8%)
Required Intervention 26 (1.1%)
Hospitalization 12 (0.5%)
Life Threatening 11 (0.5%)
R 3 (0.1%)
Disability 3 (0.1%)
L 2 (0.1%)
O 2 (0.1%)
Congenital Anomaly 2 (0.1%)
S 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 443
Low Test Results 349
High Test Results 283
Incorrect Or Inadequate Test Results 224
Non Reproducible Results 152
High Readings 137
Low Readings 109
Computer Software Problem 96
Patient Data Problem 57
Use of Device Problem 56
Incorrect Measurement 53
Blood gas measurements, erroneous 52
Output Problem 52
Device Displays Incorrect Message 46
Insufficient Device Problem Information 45
Nonstandard Device 35
Fluid/Blood Leak 31
Improper or Incorrect Procedure or Method 25
Device Operates Differently Than Expected 24
False Positive Result 21

Yearly Trend

96
1996: 2
97
1997: 53
98
1998: 3
99
1999: 2
00
2000: 2
01
2001: 28
02
2002: 18
03
2003: 10
04
2004: 7
05
2005: 19
06
2006: 21
07
2007: 16
08
2008: 40
09
2009: 74
10
2010: 20
11
2011: 50
12
2012: 64
13
2013: 62
14
2014: 93
15
2015: 55
16
2016: 118
17
2017: 206
18
2018: 174
19
2019: 141
20
2020: 117
21
2021: 147
22
2022: 138
23
2023: 177
24
2024: 196
25
2025: 212
26
2026: 127

Reports in 2025 (212) held close to the prior two-year average of 187.

Related Entities for Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Top Manufacturers

ROCHE DIAGNOSTICS 242
SIEMENS HEALTHCARE DIAGNOSTICS INC. 214

Event Locations

1,351 (56.5%)
I 850 (35.5%)
HOSPITAL 99 (4.1%)
LABORATORY 44 (1.8%)
OTHER 33 (1.4%)
NOT APPLICABLE 8 (0.3%)
NO INFORMATION 5 (0.2%)
INVALID DATA 1 (0.0%)
U 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrode Measurement: 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 (2,392 here).

Transducer, Pressure, Catheter Tip 2,389 Table, Operating-Room, Ac-Powered 2,406 Intervertebral Fusion Device With Integrate… 2,375 Electrode 2,372

Similar death-typed counts

Nearest other device types by death-typed report count (46 here), distinct from the volume row.

Catheter, Peritoneal, Long-Term Indwelling 46 Catheter, Percutaneous, Neurovasculature 47 Filler 45 Glue, Surgical, Arteries 45

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

Disclaimer: MAUDE figures for Electrode Measurement 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 Electrode Measurement; 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.