What are FDA adverse event reports for Electrode, Ion Specific, Potassium?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Electrode, Ion Specific, Potassium, there are 994 total reports including 4 death reports and 32 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Electrode, Ion Specific, Potassium?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Electrode, Ion Specific, Potassium

Name: Electrode, Ion Specific, Potassium - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Electrode, Ion Specific, Potassium LIGHT-BOOK · MAUDE

#657 of 1000 · 994 reports · 1996–2026

BOOK 994 reports
RANK #657 of 1000
DEATH 4 death-typed
INJ 32 injury-typed
MALF 943 malfunction
SPAN 1996–2026
PEAK 2008: 245
PHOTO Occluder

Nearest event-volume peer: Occluder, Patent Ductus, Arteriosus (0 report gap)

Electrode, Ion Specific, Potassium sits #657 of 1000 among tracked device types with 994 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 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
INJ 3.2% corpus 30.4% · below corpus mean (-27.2 pp)
MALF 94.9% corpus 64.5% · above corpus mean (+30.4 pp)

Lead product-problem code Low Test Results is 25% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 83% of manufacturer-tagged reports · Top event location OTHER is 38% of location-tagged rows .

Stabilizer

999
Electrode (this)

994
Occluder

994
Mouthguard

992
Prosthesis

984
Stent

984

What this shows Electrode, Ion Specific, Potassium carries 994 MAUDE reports, ranked #657 of 1000.

Event Types

Malfunction 943 (94.9%)

Injury 32 (3.2%)

Other 13 (1.3%)

Death 4 (0.4%)

2 (0.2%)

Patient Outcomes

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

951 (95.7%)

Other 23 (2.3%)

Required Intervention 9 (0.9%)

Hospitalization 6 (0.6%)

Death 5 (0.5%)

Yearly Trend

1996: 1

1997: 7

1998: 1

2000: 1

2002: 2

2003: 7

2004: 3

2006: 6

2007: 66

2008: 245

2009: 79

2010: 113

2011: 126

2012: 45

2013: 37

2014: 4

2015: 7

2016: 6

2017: 32

2018: 13

2019: 25

2020: 27

2021: 18

2022: 16

2023: 30

2024: 42

2025: 31

2026: 4

Top Manufacturers

ROCHE DIAGNOSTICS 622

ORTHO-CLINICAL DIAGNOSTICS 73

ROCHE DIAGNOSTICS CORP. 24

SIEMENS HEALTHCARE DIAGNOSTICS INC. 20

BECKMAN COULTER, INC. 14

Event Locations

OTHER 381 (38.3%)

271 (27.3%)

LABORATORY 203 (20.4%)

I 110 (11.1%)

HOSPITAL 13 (1.3%)

NOT APPLICABLE 11 (1.1%)

INVALID DATA 4 (0.4%)

U 1 (0.1%)

Compare ROCHE DIAGNOSTICS vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Electrode, Ion Specific, Potassium, 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 (994 here).

Occluder, Patent Ductus, Arteriosus 994 Mouthguard, Over-The-Counter 992 Stabilizer, Heart 999 Prosthesis 984

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

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

Electrode, Ion Specific, Potassium

Event-type mix vs corpus