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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1435 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Computer LIGHT-BOOK · MAUDE

#743 of 1000 · 778 reports · 1992–2026

  • BOOK 778 reports
  • RANK #743 of 1000
  • DEATH 16 death-typed
  • INJ 32 injury-typed
  • MALF 723 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 83
  • PHOTO Appliance

Nearest event-volume peer: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (1 report gap)

Computer, Diagnostic, Pre-Programmed, Single-Function sits #743 of 1000 among tracked device types with 778 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 →

Malfunction reports run above the device-type norm

Computer carries 92.9% MALFUNCTION-coded reports, 28.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.5 pp)
  • INJ 4.1% corpus 30.3% · below corpus mean (-26.2 pp)
  • MALF 92.9% corpus 64.8% · above corpus mean (+28.1 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 40% 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 778 MAUDE reports, ranked #743 of 1000.

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

Event Types

Malfunction 723 (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.

669 (85.9%)
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, Inadequate or Imprecise Result or Readings 320
Incorrect Measurement 243
Smoking 52
Break 16
Fluid/Blood Leak 16
Fire 15
Sparking 14
Device Displays Incorrect Message 12
Leak/Splash 12
Low Readings 12
Display or Visual Feedback Problem 11
Output Problem 11
Thermal Decomposition of Device 10
False Reading From Device Non-Compliance 9
Device Alarm System 8
High Test Results 8
Operating System Becomes Nonfunctional 8
Temperature Problem 8
Device Operates Differently Than Expected 7
Measurements, inaccurate 7

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: 4

Reports in 2025 (12) held close to the prior two-year average of 18.

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 (48.8%)
HOSPITAL 191 (24.6%)
187 (24.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Computer: 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 (778 here).

Appliance 779 Electrocautery, Gynecologic 777 Cleanser, Denture, Over The Counter 776 Gown, Surgical 780

Similar death-typed counts

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

Catheter And Tip, Suction 16 Dilator, Esophageal 16 Implanted Subcortical Electrical Stimulator 16 Stent 16

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.