2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Electrode Measurement LIGHT-BOOK · MAUDE

#452 of 1000 · 2,287 reports · 1996–2026

  • BOOK 2,287 reports
  • RANK #452 of 1000
  • DEATH 45 death-typed
  • INJ 68 injury-typed
  • MALF 2,007 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 212
  • PHOTO Transducer

Nearest event-volume peer: Transducer, Pressure, Catheter Tip (10 report gap)

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph sits #452 of 1000 among tracked device types with 2,287 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 →

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 2.0% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 3.0% corpus 30.4% · below corpus mean (-27.5 pp)
  • MALF 87.8% corpus 64.5% · above corpus mean (+23.3 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 24% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 55% of manufacturer-tagged reports · Top event location is 55% 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 2,287 MAUDE reports, ranked #452 of 1000.

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

Event Types

Malfunction 2,007 (87.8%)
Other 96 (4.2%)
71 (3.1%)
Injury 68 (3.0%)
Death 45 (2.0%)

Patient Outcomes

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

2,048 (89.3%)
Other 142 (6.2%)
Death 42 (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 385
Low Test Results 195
High Test Results 182
Non Reproducible Results 152
High Readings 123
Incorrect Or Inadequate Test Results 93
Low Readings 79
Computer Software Problem 74
Incorrect Measurement 49
Output Problem 48
Insufficient Information 43
Use of Device Problem 42
Patient Data Problem 38
False Positive Result 19
Erratic Results 18
Adverse Event Without Identified Device or Use Problem 17
False Negative Result 16
No Device Output 15
Device Displays Incorrect Message 14
Fluid/Blood Leak 14

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: 22

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

Event Locations

1,247 (54.5%)
I 850 (37.2%)
HOSPITAL 98 (4.3%)
LABORATORY 44 (1.9%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Electrode Measurement, 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 (2,287 here).

Similar death-typed counts

Nearest other device types by death-typed report count (45 here), distinct from the volume row.

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.