Computer, Diagnostic, Programmable
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 §870.1425 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Computer, Diagnostic, Programmable LIGHT-BOOK · MAUDE
#340 of 1000 · 4,441 reports · 1997–2026
- BOOK 4,441 reports
- RANK #340 of 1000
- DEATH 53 death-typed
- INJ 608 injury-typed
- MALF 3,757 malfunction
- SPAN 1997–2026
- PEAK 2024: 557
- PHOTO Stimulator
Nearest event-volume peer: Stimulator, Peripheral Nerve, Implanted (Pain Relief) (33 report gap)
Computer, Diagnostic, Programmable sits #340 of 1000 among tracked device types with 4,441 MAUDE reports spanning 1997–2026. 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
Computer, Diagnostic, Programmable carries 84.6% MALFUNCTION-coded reports, 19.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
- INJ 13.7% corpus 30.3% · below corpus mean (-16.6 pp)
- MALF 84.6% corpus 64.8% · above corpus mean (+19.8 pp)
Lead product-problem code Communication or Transmission Problem is 17% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 32% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .
Computer, Diagnostic, Programmable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stimulator
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
4,474 reports
- Computer (this)
Computer, Diagnostic, Programmable
4,441 reports
- Pack
Pack, Hot Or Cold, Disposable
4,404 reports
- Orthosis
Orthosis, Spondylolisthesis Spinal Fixation
4,392 reports
- System
System, Hypothermia, Intravenous, Cooling
4,389 reports
- Intestinal St…
Intestinal Stimulator
4,382 reports
What this shows Computer, Diagnostic, Programmable carries 4,441 MAUDE reports, ranked #340 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 (440) held close to the prior two-year average of 449.
Related Entities for Computer, Diagnostic, Programmable
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Computer, Diagnostic, Programmable: 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 (4,441 here).
Similar death-typed counts
Nearest other device types by death-typed report count (53 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Computer, Diagnostic, Programmable 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 Computer, Diagnostic, Programmable; 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.