Electrode, Ion Specific, Potassium
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 §862.1600 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Electrode, Ion Specific, Potassium LIGHT-BOOK · MAUDE
#661 of 1000 · 1,008 reports · 1996–2026
- BOOK 1,008 reports
- RANK #661 of 1000
- DEATH 4 death-typed
- INJ 32 injury-typed
- MALF 957 malfunction
- SPAN 1996–2026
- PEAK 2008: 245
- PHOTO Mouthguard
Nearest event-volume peer: Mouthguard, Over-The-Counter (2 report gap)
Electrode, Ion Specific, Potassium sits #661 of 1000 among tracked device types with 1,008 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 →
Malfunction reports run above the device-type norm
Electrode, Ion Specific, Potassium carries 94.9% MALFUNCTION-coded reports, 30.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
- MALF 94.9% corpus 64.8% · above corpus mean (+30.1 pp)
Lead product-problem code Low Test Results is 35% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 85% of manufacturer-tagged reports · Top event location OTHER is 38% of location-tagged rows .
Electrode, Ion Specific, Potassium in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Bath
Bath, Hydro-Massage
1,022 reports
- Electrode (this)
Electrode, Ion Specific, Potassium
1,008 reports
- Mouthguard
Mouthguard, Over-The-Counter
1,006 reports
- Filter
Filter, Bacterial, Breathing-Circuit
1,004 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
1,004 reports
- Mixer
Mixer, Cement, For Clinical Use
998 reports
What this shows Electrode, Ion Specific, Potassium carries 1,008 MAUDE reports, ranked #661 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (29) held close to the prior two-year average of 36.
Related Entities for Electrode, Ion Specific, Potassium
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Electrode, Ion Specific, Potassium: 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 (1,008 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 here), distinct from the volume row.
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.