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2026 data FDA MAUDE openFDA FDA Class II

Probe, Thermodilution

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 §870.1915 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Probe, Thermodilution LIGHT-BOOK · MAUDE

#989 of 1000 · 373 reports · 1992–2026

  • BOOK 373 reports
  • RANK #989 of 1000
  • DEATH 5 death-typed
  • INJ 50 injury-typed
  • MALF 314 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 45
  • PHOTO Crutch

Nearest event-volume peer: Crutch (0 report gap)

Probe, Thermodilution sits #989 of 1000 among tracked device types with 373 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

Probe, Thermodilution carries 84.2% MALFUNCTION-coded reports, 19.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 13.4% corpus 30.3% · below corpus mean (-16.9 pp)
  • MALF 84.2% corpus 64.8% · above corpus mean (+19.4 pp)

Lead product-problem code Break is 14% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 63% of manufacturer-tagged reports · Top event location I is 37% of location-tagged rows .

Probe, Thermodilution in the event-volume neighbourhood

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

reports

What this shows Probe, Thermodilution carries 373 MAUDE reports, ranked #989 of 1000.

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

Event Types

Malfunction 314 (84.2%)
Injury 50 (13.4%)
Death 5 (1.3%)
3 (0.8%)
Other 1 (0.3%)

Patient Outcomes

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

290 (77.1%)
Required Intervention 41 (10.9%)
Other 25 (6.6%)
Death 5 (1.3%)
S 4 (1.1%)
Disability 4 (1.1%)
Life Threatening 4 (1.1%)
Hospitalization 2 (0.5%)
R 1 (0.3%)

Top Product Problems

Break 47
Leak/Splash 46
Deflation Problem 31
Material Fragmentation 31
Fluid/Blood Leak 30
Adverse Event Without Identified Device or Use Problem 26
Incorrect Measurement 22
Stretched 20
Crack 18
Incorrect, Inadequate or Imprecise Result or Readings 11
Material Rupture 9
Difficult to Insert 8
Fracture 7
Measurements, inaccurate 7
Uncoiled 7
Detachment of Device or Device Component 6
Disconnection 6
Connection Problem 5
Device Contamination with Chemical or Other Material 5
Appropriate Device Problem Term/Code Not Available 4

Yearly Trend

92
1992: 4
94
1994: 1
96
1996: 1
97
1997: 1
99
1999: 1
07
2007: 1
08
2008: 2
09
2009: 8
10
2010: 2
11
2011: 15
12
2012: 20
13
2013: 11
14
2014: 14
15
2015: 45
16
2016: 25
17
2017: 24
18
2018: 18
19
2019: 26
20
2020: 16
21
2021: 22
22
2022: 21
23
2023: 13
24
2024: 40
25
2025: 24
26
2026: 18

Reports in 2025 (24) held close to the prior two-year average of 27.

Related Entities for Probe, Thermodilution

Top Manufacturers

EDWARDS LIFESCIENCES, PR 79
EDWARDS LIFESCIENCES PR 20
EDWARDS LIFESCIENCES 16
ICU MEDICAL, INC. 7
MAQUET CRITICAL CARE AB 4

Event Locations

I 139 (37.3%)
137 (36.7%)
HOSPITAL 79 (21.2%)
NO INFORMATION 16 (4.3%)
CATHETERIZATION SUITE 1 (0.3%)
INVALID DATA 1 (0.3%)

Compare EDWARDS LIFESCIENCES, PR vs EDWARDS LIFESCIENCES PR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Probe, Thermodilution: 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 (373 here).

Crutch 373 Azo Dye, Calcium 372 Lens, Contact, 372 Multi-Analyte Test System With Algorithmic… 371

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 Probe, Thermodilution 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 Probe, Thermodilution; 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.