What are FDA adverse event reports for System, Thermal Regulating?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For System, Thermal Regulating, there are 25,855 total reports including 52 death reports and 2,150 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for System, Thermal Regulating?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

System, Thermal Regulating

Name: System, Thermal Regulating - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book System, Thermal Regulating MID-BOOK · MAUDE

#115 of 1000 · 25,855 reports · 1992–2026

BOOK 25,855 reports
RANK #115 of 1000
DEATH 52 death-typed
INJ 2,150 injury-typed
MALF 23,464 malfunction
SPAN 1992–2026
PEAK 2023: 3,455
PHOTO Stapler, Surgical

Nearest event-volume peer: Stapler, Surgical (81 report gap)

System, Thermal Regulating sits #115 of 1000 among tracked device types with 25,855 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
INJ 8.3% corpus 30.4% · below corpus mean (-22.1 pp)
MALF 90.8% corpus 64.5% · above corpus mean (+26.2 pp)

Lead product-problem code Defective Component is 12% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 67% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Bronchoscope

26,266
Device

25,981
Stapler

25,936
System (this)

25,855
Wheelchair

25,664
Prosthesis

25,649

What this shows System, Thermal Regulating carries 25,855 MAUDE reports, ranked #115 of 1000.

Event Types

Malfunction 23,464 (90.8%)

Injury 2,150 (8.3%)

Other 118 (0.5%)

71 (0.3%)

Death 52 (0.2%)

Patient Outcomes

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

Other 15,500 (57.2%)

7,324 (27.0%)

Required Intervention 2,300 (8.5%)

Hospitalization 597 (2.2%)

S 546 (2.0%)

R 523 (1.9%)

L 153 (0.6%)

Death 58 (0.2%)

O 56 (0.2%)

H 19 (0.1%)

Life Threatening 16 (0.1%)

Disability 15 (0.1%)

D 1 (0.0%)

Invalid Data 1 (0.0%)

Yearly Trend

1992: 3

1993: 3

1994: 8

1995: 5

1996: 18

1997: 23

1998: 14

1999: 15

2000: 20

2001: 13

2002: 27

2003: 20

2004: 18

2005: 10

2006: 32

2007: 52

2008: 40

2009: 71

2010: 104

2011: 136

2012: 106

2013: 73

2014: 116

2015: 245

2016: 1,401

2017: 1,473

2018: 1,517

2019: 2,294

2020: 2,546

2021: 2,689

2022: 3,226

2023: 3,455

2024: 3,329

2025: 2,427

2026: 326

Top Manufacturers

STRYKER MEDICAL-KALAMAZOO 445

SMITHS MEDICAL ASD, INC. 215

Event Locations

15,042 (58.2%)

I 9,621 (37.2%)

NO INFORMATION 612 (2.4%)

HOSPITAL 537 (2.1%)

INVALID DATA 11 (0.0%)

AMBULATORY SURGICAL FACILITY 10 (0.0%)

OTHER 9 (0.0%)

HOME 7 (0.0%)

UNKNOWN 4 (0.0%)

OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare STRYKER MEDICAL-KALAMAZOO vs SMITHS MEDICAL ASD, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Thermal Regulating, 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 (25,855 here).

Stapler, Surgical 25,936 Device, Neurovascular Embolization 25,981 Wheelchair, Mechanical 25,664 Prosthesis 25,649

Similar death-typed counts

Nearest other device types by death-typed report count (52 here), distinct from the volume row.

Computer, Diagnostic, Programmable 53 Gastroscope And Accessories, Flexible/Rigid 53 Prosthesis 51 Test, Time, Prothrombin 51

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

Disclaimer: MAUDE figures for System, Thermal Regulating 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 System, Thermal Regulating; 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.

System, Thermal Regulating

Event-type mix vs corpus