PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Instrument, Coagulation, Automated

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 §864.5400 (Hematology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Instrument, Coagulation, Automated LIGHT-BOOK · MAUDE

#795 of 1000 · 661 reports · 1994–2026

  • BOOK 661 reports
  • RANK #795 of 1000
  • DEATH 13 death-typed
  • INJ 70 injury-typed
  • MALF 531 malfunction
  • SPAN 1994–2026
  • PEAK 2009: 190
  • PHOTO Full Field Digital

Nearest event-volume peer: Full Field Digital, System, X-Ray, Mammographic (2 report gap)

Instrument, Coagulation, Automated sits #795 of 1000 among tracked device types with 661 MAUDE reports spanning 1994–2026. 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Instrument, Coagulation, Automated carries 10.6% INJURY-coded reports, 19.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.0% corpus 1.5% · near corpus mean (+0.5 pp)
  • INJ 10.6% corpus 30.3% · below corpus mean (-19.7 pp)
  • MALF 80.3% corpus 64.8% · above corpus mean (+15.5 pp)

Lead product-problem code Low Test Results is 33% of coded problems · Top event location is 73% of location-tagged rows .

Instrument, Coagulation, Automated in the event-volume neighbourhood

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

reports

What this shows Instrument, Coagulation, Automated carries 661 MAUDE reports, ranked #795 of 1000.

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

Event Types

Malfunction 531 (80.3%)
Injury 70 (10.6%)
Other 32 (4.8%)
15 (2.3%)
Death 13 (2.0%)

Patient Outcomes

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

317 (47.2%)
Other 292 (43.5%)
Required Intervention 21 (3.1%)
Hospitalization 14 (2.1%)
Death 11 (1.6%)
R 7 (1.0%)
Life Threatening 5 (0.7%)
L 2 (0.3%)
S 2 (0.3%)
Invalid Data 1 (0.1%)

Top Product Problems

Low Test Results 217
High Test Results 134
Incorrect Or Inadequate Test Results 104
Incorrect, Inadequate or Imprecise Result or Readings 45
Adverse Event Without Identified Device or Use Problem 38
Device Displays Incorrect Message 25
Use of Device Problem 20
Insufficient Device Problem Information 11
False Reading From Device Non-Compliance 10
Improper or Incorrect Procedure or Method 9
Computer Software Problem 8
Coagulation in Device or Device Ingredient 7
Device Operates Differently Than Expected 6
Unknown (for use when the device problem is not known) 6
Data Problem 5
Replace 5
Burst Container or Vessel 4
Mechanical Problem 4
Smoking 4
Break 3

Yearly Trend

94
1994: 1
95
1995: 7
96
1996: 5
97
1997: 7
98
1998: 4
99
1999: 3
00
2000: 4
01
2001: 1
02
2002: 1
03
2003: 5
04
2004: 8
05
2005: 36
06
2006: 2
07
2007: 3
08
2008: 5
09
2009: 190
10
2010: 74
11
2011: 45
12
2012: 35
13
2013: 42
14
2014: 26
15
2015: 24
16
2016: 13
17
2017: 18
18
2018: 19
19
2019: 38
20
2020: 14
21
2021: 17
22
2022: 4
23
2023: 4
24
2024: 5
26
2026: 1

Reports in 2024 (5) held close to the prior two-year average of 4.

Related Entities for Instrument, Coagulation, Automated

Event Locations

483 (73.1%)
I 126 (19.1%)
HOSPITAL 27 (4.1%)
NOT APPLICABLE 15 (2.3%)
NO INFORMATION 4 (0.6%)
OTHER 3 (0.5%)
INVALID DATA 2 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument, Coagulation, Automated: 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 (661 here).

Full Field Digital 659 Accessories, Cleaning Brushes, For Endoscope 664 Guide, Wire, Catheter, Neurovasculature 657 Endoscope Channel Accessory 666

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Apparatus 13 Bariatric Bed 13 Chair, With Casters 13 Continuous Measurement Thermometer 13

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

Disclaimer: MAUDE figures for Instrument, Coagulation, Automated 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 Instrument, Coagulation, Automated; 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.