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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Computer, Diagnostic, Programmable LIGHT-BOOK · MAUDE

#344 of 1000 · 4,214 reports · 1997–2026

  • BOOK 4,214 reports
  • RANK #344 of 1000
  • DEATH 53 death-typed
  • INJ 591 injury-typed
  • MALF 3,547 malfunction
  • SPAN 1997–2026
  • PEAK 2024: 557
  • PHOTO Stretcher

Nearest event-volume peer: Stretcher, Wheeled, Powered (4 report gap)

Computer, Diagnostic, Programmable sits #344 of 1000 among tracked device types with 4,214 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 →

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 1.3% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 14.0% corpus 30.4% · below corpus mean (-16.4 pp)
  • MALF 84.2% corpus 64.5% · above corpus mean (+19.7 pp)

Lead product-problem code Communication or Transmission Problem is 19% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 34% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Computer, Diagnostic, Programmable in the event-volume neighbourhood

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

reports

What this shows Computer, Diagnostic, Programmable carries 4,214 MAUDE reports, ranked #344 of 1000.

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

Event Types

Malfunction 3,547 (84.2%)
Injury 591 (14.0%)
Death 53 (1.3%)
Other 14 (0.3%)
9 (0.2%)

Patient Outcomes

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

3,497 (81.1%)
Other 456 (10.6%)
Required Intervention 82 (1.9%)
Hospitalization 62 (1.4%)
R 59 (1.4%)
Death 54 (1.3%)
Life Threatening 53 (1.2%)
L 31 (0.7%)
O 11 (0.3%)
H 4 (0.1%)
S 3 (0.1%)
D 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Communication or Transmission Problem 539
Display or Visual Feedback Problem 404
Failure to Transmit Record 198
Incorrect Measurement 193
Incorrect, Inadequate or Imprecise Result or Readings 176
Signal Artifact/Noise 172
Application Program Problem 123
Application Interface Becomes Non-Functional Or Program Exits Abnormally 113
Output Problem 105
Device Issue 90
Adverse Event Without Identified Device or Use Problem 89
Computer Software Problem 89
Device Operational Issue 88
Failure of Device to Self-Test 87
No Display/Image 83
Image Orientation Incorrect 81
Data Problem 75
Failure to Power Up 72
Pacing Problem 62
Device Displays Incorrect Message 60

Yearly Trend

97
1997: 3
98
1998: 11
99
1999: 1
00
2000: 18
01
2001: 5
02
2002: 5
03
2003: 6
04
2004: 3
05
2005: 14
06
2006: 14
07
2007: 18
08
2008: 34
09
2009: 40
10
2010: 49
11
2011: 55
12
2012: 129
13
2013: 180
14
2014: 115
15
2015: 131
16
2016: 340
17
2017: 252
18
2018: 261
19
2019: 218
20
2020: 215
21
2021: 351
22
2022: 319
23
2023: 340
24
2024: 557
25
2025: 440
26
2026: 90

Related Entities for Computer, Diagnostic, Programmable

Top Manufacturers

ST. JUDE MEDICAL, INC. 789
BIOSENSE WEBSTER INC 530
ST. JUDE MEDICAL 328
EDWARDS LIFESCIENCES 294
BOSTON SCIENTIFIC CORPORATION 225
ABBOTT MEDICAL 123

Event Locations

2,431 (57.7%)
I 1,496 (35.5%)
HOSPITAL 205 (4.9%)
OTHER 66 (1.6%)
NO INFORMATION 13 (0.3%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ST. JUDE MEDICAL, INC. vs BIOSENSE WEBSTER INC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Computer, Diagnostic, Programmable, 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 (4,214 here).

Stretcher, Wheeled, Powered 4,210 Battery, Replacement, Rechargeable 4,251 Pump 4,251 Pack, Hot Or Cold, Disposable 4,263

Similar death-typed counts

Nearest other device types by death-typed report count (53 here), distinct from the volume row.

Gastroscope And Accessories, Flexible/Rigid 53 Occluder, Patent Ductus, Arteriosus 54 System, Thermal Regulating 52 Wheelchair, Mechanical 54

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.