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2026 data FDA MAUDE openFDA

Computer, Diagnostic, Pre-Programmed, Single-Function

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 LIGHT-BOOK · MAUDE

#731 of 1000 · 775 reports · 1992–2026

  • BOOK 775 reports
  • RANK #731 of 1000
  • DEATH 16 death-typed
  • INJ 32 injury-typed
  • MALF 720 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 83
  • PHOTO Cleanser

Nearest event-volume peer: Cleanser, Denture, Over The Counter (1 report gap)

Computer, Diagnostic, Pre-Programmed, Single-Function sits #731 of 1000 among tracked device types with 775 MAUDE reports spanning 1992–2026. 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 2.1% corpus 1.5% · above corpus mean (+0.5 pp)
  • INJ 4.1% corpus 30.4% · below corpus mean (-26.3 pp)
  • MALF 92.9% corpus 64.5% · above corpus mean (+28.4 pp)

Lead product-problem code Incorrect Measurement is 35% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 94% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Computer in the event-volume neighbourhood

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

reports

What this shows Computer, Diagnostic, Pre-Programmed, Single-Function carries 775 MAUDE reports, ranked #731 of 1000.

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

Event Types

Malfunction 720 (92.9%)
Injury 32 (4.1%)
Death 16 (2.1%)
Other 6 (0.8%)
1 (0.1%)

Patient Outcomes

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

666 (85.8%)
Other 56 (7.2%)
Required Intervention 30 (3.9%)
Death 17 (2.2%)
Hospitalization 3 (0.4%)
R 2 (0.3%)
O 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Incorrect Measurement 211
Incorrect, Inadequate or Imprecise Result or Readings 209
Smoking 29
Fire 13
Sparking 12
Break 11
Display or Visual Feedback Problem 11
Leak/Splash 11
Output Problem 11
Device Displays Incorrect Message 10
Fluid/Blood Leak 10
High Test Results 8
Operating System Becomes Nonfunctional 8
Temperature Problem 8
Device Operates Differently Than Expected 7
Unable to Obtain Readings 7
Device Alarm System 6
Electrical Power Problem 6
Inaccurate Information 6
No Display/Image 6

Yearly Trend

92
1992: 28
93
1993: 16
94
1994: 5
96
1996: 2
97
1997: 2
98
1998: 1
99
1999: 2
00
2000: 1
02
2002: 4
03
2003: 1
04
2004: 2
05
2005: 2
06
2006: 4
07
2007: 43
08
2008: 37
09
2009: 8
10
2010: 17
11
2011: 7
12
2012: 29
13
2013: 23
14
2014: 44
15
2015: 34
16
2016: 67
17
2017: 62
18
2018: 83
19
2019: 81
20
2020: 49
21
2021: 29
22
2022: 44
23
2023: 12
24
2024: 23
25
2025: 12
26
2026: 1

Related Entities for Computer, Diagnostic, Pre-Programmed, Single-Function

Top Manufacturers

EDWARDS LIFESCIENCES 602
ICU MEDICAL, INC. 11
EDWARDS LIFESCIENCES, LLC 6
EDWARDS LIFESCIENCES LLC 5
HOSPIRA, INC. 5
UNKNOWN 5
ABBOTT LABORATORIES 4

Event Locations

I 380 (49.0%)
HOSPITAL 191 (24.6%)
184 (23.7%)
OTHER 7 (0.9%)
HOME 4 (0.5%)
INVALID DATA 4 (0.5%)
NO INFORMATION 2 (0.3%)
OUTPATIENT TREATMENT FACILITY 2 (0.3%)
LABORATORY 1 (0.1%)

Compare EDWARDS LIFESCIENCES vs ICU MEDICAL, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Computer, 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 (775 here).

Cleanser, Denture, Over The Counter 776 Adhesive 773 Appliance 777 Instrument, Compression 778

Similar death-typed counts

Nearest other device types by death-typed report count (16 here), distinct from the volume row.

Dilator, Esophageal 16 Gastrointestinal Tubes With Enteral Specifi… 16 Implanted Subcortical Electrical Stimulator 16 Accessories, Blood Circuit, Hemodialysis 17

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

Disclaimer: MAUDE figures for Computer 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; 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.