System, Thermal Regulating
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 §870.5900 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book System, Thermal Regulating MID-BOOK · MAUDE
#114 of 1000 · 26,611 reports · 1992–2026
- BOOK 26,611 reports
- RANK #114 of 1000
- DEATH 54 death-typed
- INJ 2,191 injury-typed
- MALF 24,177 malfunction
- SPAN 1992–2026
- PEAK 2023: 3,455
- PHOTO Stapler, Surgical
Nearest event-volume peer: Stapler, Surgical (18 report gap)
System, Thermal Regulating sits #114 of 1000 among tracked device types with 26,611 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
System, Thermal Regulating carries 90.9% MALFUNCTION-coded reports, 26.0pp 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 8.2% corpus 30.3% · below corpus mean (-22.1 pp)
- MALF 90.9% corpus 64.8% · above corpus mean (+26.0 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 59% of location-tagged rows .
System, Thermal Regulating in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Coronavirus A…
Coronavirus Antigen Detection Test System.
26,743 reports
- Stapler
Stapler, Surgical
26,629 reports
- System (this)
System, Thermal Regulating
26,611 reports
- Test
Test, Time, Prothrombin
26,539 reports
- Wheelchair
Wheelchair, Mechanical
26,370 reports
- Device
Device, Neurovascular Embolization
26,211 reports
What this shows System, Thermal Regulating carries 26,611 MAUDE reports, ranked #114 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (2,431) held close to the prior two-year average of 3,392.
Related Entities for System, Thermal Regulating
Top Manufacturers
Event Locations
Compare STRYKER MEDICAL-KALAMAZOO vs SMITHS MEDICAL ASD, INC. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System, Thermal Regulating: 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 (26,611 here).
Similar death-typed counts
Nearest other device types by death-typed report count (54 here), distinct from the volume row.
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.