Hyperthermia Monitor
Cardiovascular · 21 CFR 870.5900
Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).
Recent MDR events
10 adverse event reports on file
- THERMOGARD¿ VEST, L/XLMar 25, 2026InjuryZoll Circulation, Inc.3010617000-2026-00169
- THERMOGARD¿ VEST, L/XLMar 25, 2026InjuryZoll Circulation, Inc.3010617000-2026-00170
- THERMOGARD¿ VEST, L/XLMar 25, 2026InjuryZoll Circulation3010617000-2026-00166
- THERMOGARD¿ VEST, L/XLMar 25, 2026InjuryZoll Circulation3010617000-2026-00167
- THERMOGARD¿ VEST, L/XLMar 25, 2026InjuryZoll Circulation3010617000-2026-00168
- THERMOGARD¿ VEST, L/XLMar 25, 2026InjuryZoll Circulation3010617000-2026-00165
- TSP-50 THERMOSUIT PUMP CONTROLLER CONSOLEFeb 16, 2026MalfunctionLife Recovery Systems3006059109-2026-00001
- THERMOGARD¿ VEST, L/XLAug 13, 2024InjuryZoll Circulation, Inc.3010617000-2024-00610
- STX VESTMay 22, 2024InjuryZoll Circulation3010617000-2024-00406
- THERMOSUIT SYSTEMAug 31, 2011DeathLife Recovery Systems Hd, Llc3006059109-2011-00001
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
6 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Zoll Circulation, Inc.Oct 15, 2025
K250979 · Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- Global Healthcare SG Sdn. BhdMar 18, 2025
K240933 · CarbonCool® System
- Zoll Circulation, Inc.Nov 3, 2023
K231182 · Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
- Braincool ABMay 3, 2017
K162523 · The IQool System
- Emcools Emergency Medical Cooling Systems AGOct 12, 2010
K100071 · EMCOOLSPAD
- Life Recovery Systems Hd, LLCSep 20, 2006
K061023 · THERMOSUIT SYSTEM