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2026 data FDA MAUDE openFDA

Electrode, Ion Specific, Sodium

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 Electrode, Ion Specific, Sodium LIGHT-BOOK · MAUDE

#351 of 1000 · 3,925 reports · 1998–2026

  • BOOK 3,925 reports
  • RANK #351 of 1000
  • DEATH 3 death-typed
  • INJ 91 injury-typed
  • MALF 3,726 malfunction
  • SPAN 1998–2026
  • PEAK 2011: 912
  • PHOTO Ultrasound Bronchosco…

Nearest event-volume peer: Ultrasound Bronchoscope (44 report gap)

Electrode, Ion Specific, Sodium sits #351 of 1000 among tracked device types with 3,925 MAUDE reports spanning 1998–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.3% corpus 30.4% · below corpus mean (-28.1 pp)
  • MALF 94.9% corpus 64.5% · above corpus mean (+30.4 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 45% of coded problems · Lead manufacturer BECKMAN COULTER, INC. accounts for 31% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Electrode, Ion Specific, Sodium in the event-volume neighbourhood

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

reports

What this shows Electrode, Ion Specific, Sodium carries 3,925 MAUDE reports, ranked #351 of 1000.

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

Event Types

Malfunction 3,726 (94.9%)
Other 100 (2.5%)
Injury 91 (2.3%)
5 (0.1%)
Death 3 (0.1%)

Patient Outcomes

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

3,751 (95.5%)
Other 78 (2.0%)
Hospitalization 56 (1.4%)
Required Intervention 32 (0.8%)
Death 4 (0.1%)
O 3 (0.1%)
Congenital Anomaly 2 (0.1%)
R 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 587
High Test Results 260
Low Test Results 217
Non Reproducible Results 94
Incorrect Or Inadequate Test Results 66
High Readings 14
Misassembly During Maintenance/Repair 12
False Positive Result 9
Incorrect Measurement 9
Insufficient Information 8
Low Readings 8
Output Problem 8
Nonstandard Device 7
False Negative Result 4
Adverse Event Without Identified Device or Use Problem 3
Device Operates Differently Than Expected 3
Calibration Problem 2
Failure to Calibrate 2
Mechanical Problem 2
No Apparent Adverse Event 2

Yearly Trend

98
1998: 1
01
2001: 1
02
2002: 3
03
2003: 12
04
2004: 19
05
2005: 24
06
2006: 9
07
2007: 33
08
2008: 3
09
2009: 57
10
2010: 361
11
2011: 912
12
2012: 412
13
2013: 510
14
2014: 251
15
2015: 158
16
2016: 84
17
2017: 292
18
2018: 158
19
2019: 105
20
2020: 89
21
2021: 91
22
2022: 60
23
2023: 98
24
2024: 96
25
2025: 68
26
2026: 18

Related Entities for Electrode, Ion Specific, Sodium

Top Manufacturers

BECKMAN COULTER, INC. 830
ROCHE DIAGNOSTICS 635
BECKMAN COULTER INC. 397
BECKMAN COULTER 218
ORTHO-CLINICAL DIAGNOSTICS 202
SIEMENS HEALTHCARE DIAGNOSTICS INC. 179
SIEMENS HEALTHCARE DIAGNOSTICS INC 151
ABBOTT MANUFACTURING INC 90

Event Locations

2,687 (68.5%)
I 777 (19.8%)
LABORATORY 381 (9.7%)
OTHER 69 (1.8%)
NOT APPLICABLE 5 (0.1%)
NO INFORMATION 3 (0.1%)
HOSPITAL 2 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)

Compare BECKMAN COULTER, INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Electrode, Ion Specific, Sodium, 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 (3,925 here).

Ultrasound Bronchoscope 3,881 Orthosis, Spinal Pedicle Fixation 3,970 Prosthesis, Hip, Semi-Constrained 3,870 Instrument, Manual, Surgical, General Use 4,020

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Electrode, Ion Specific, Sodium 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, Ion Specific, Sodium; 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.