PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Calculator/Data Processing Module, For Clinical Use

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §862.2100 (Clinical Chemistry panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Calculator/Data Processing Module LIGHT-BOOK · MAUDE

#478 of 1000 · 2,167 reports · 1999–2026

  • BOOK 2,167 reports
  • RANK #478 of 1000
  • DEATH 5 death-typed
  • INJ 106 injury-typed
  • MALF 1,984 malfunction
  • SPAN 1999–2026
  • PEAK 2019: 253
  • PHOTO Catheter, Subclavian

Nearest event-volume peer: Catheter, Subclavian (3 report gap)

Calculator/Data Processing Module, For Clinical Use sits #478 of 1000 among tracked device types with 2,167 MAUDE reports spanning 1999–2026. 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

Calculator/Data Processing Module carries 91.6% MALFUNCTION-coded reports, 26.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 4.9% corpus 30.3% · below corpus mean (-25.4 pp)
  • MALF 91.6% corpus 64.8% · above corpus mean (+26.7 pp)

Lead product-problem code Missing Information is 16% of coded problems · Lead manufacturer ABBOTT MANUFACTURING INC accounts for 32% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Calculator/Data Processing Module in the event-volume neighbourhood

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

reports

What this shows Calculator/Data Processing Module, For Clinical Use carries 2,167 MAUDE reports, ranked #478 of 1000.

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

Event Types

Malfunction 1,984 (91.6%)
Injury 106 (4.9%)
Other 45 (2.1%)
27 (1.2%)
Death 5 (0.2%)

Patient Outcomes

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

1,986 (91.0%)
Other 98 (4.5%)
Required Intervention 50 (2.3%)
Hospitalization 13 (0.6%)
O 7 (0.3%)
Life Threatening 7 (0.3%)
Death 6 (0.3%)
R 5 (0.2%)
Disability 4 (0.2%)
L 3 (0.1%)
S 2 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Missing Information 290
Incorrect, Inadequate or Imprecise Result or Readings 275
Computer Software Problem 216
Patient Data Problem 127
Data Problem 94
Application Program Problem 90
Use of Device Problem 86
Incorrect Or Inadequate Test Results 67
Device Operates Differently Than Expected 65
Output Problem 62
Adverse Event Without Identified Device or Use Problem 56
High Test Results 55
Low Test Results 54
Smoking 52
Improper or Incorrect Procedure or Method 46
Product Quality Problem 41
Device Operational Issue 40
Insufficient Device Problem Information 38
Charred 36
Device Displays Incorrect Message 36

Yearly Trend

99
1999: 2
00
2000: 4
01
2001: 5
02
2002: 2
03
2003: 4
04
2004: 1
05
2005: 5
06
2006: 5
07
2007: 22
08
2008: 9
09
2009: 14
10
2010: 45
11
2011: 128
12
2012: 102
13
2013: 46
14
2014: 85
15
2015: 142
16
2016: 205
17
2017: 110
18
2018: 218
19
2019: 253
20
2020: 52
21
2021: 105
22
2022: 166
23
2023: 171
24
2024: 102
25
2025: 119
26
2026: 45

Reports in 2025 (119) held close to the prior two-year average of 137.

Related Entities for Calculator/Data Processing Module, For Clinical Use

Top Manufacturers

ABBOTT MANUFACTURING INC 436
ROCHE DIAGNOSTICS 316
SIEMENS HEALTHCARE DIAGNOSTICS INC. 195
BECTON, DICKINSON & CO. (SPARKS) 140
BAXTER HEALTHCARE CORPORATION 104
BECTON DICKINSON & CO. (SPARKS) 79
BECKMAN COULTER, INC. 74

Event Locations

1,105 (51.0%)
I 967 (44.6%)
LABORATORY 43 (2.0%)
NO INFORMATION 23 (1.1%)
HOSPITAL 15 (0.7%)
OTHER 6 (0.3%)
NOT APPLICABLE 5 (0.2%)
U 2 (0.1%)
EMERGENCY ROOM 1 (0.0%)

Compare ABBOTT MANUFACTURING INC vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Calculator/Data Processing Module: 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 (2,167 here).

Catheter, Subclavian 2,170 Pin, Fixation, Threaded 2,172 Temporary Non-Roller Type Right Heart Suppo… 2,154 Adaptor 2,152

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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

Disclaimer: MAUDE figures for Calculator/Data Processing Module 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 Calculator/Data Processing Module; 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.