EnsoETM ECD01-A (UDI 00857915006043)Recalls & reported problems
Advanced Cooling Therapy, LLC · The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, and provide gastric decompression and suctioning. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857915006043), received between May 13, 2019 and May 13, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Temperature Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Temperature Problem1
Patient problems
- Alteration In Body Temperature1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2019Temperature Problem
PATIENT UNDERGOING TARGETED TEMPERATURE MANAGEMENT USING GAYMAR MACHINE AND WRAPS. DURING MAINTENANCE PORTION OF PROTOCOL, MACHINE NOTED TO BE HEATING WATER TEMPERATURE AND ELEVATING PATIENT'S CORE TEMP BEYOND DESIRED NUMBER. RN EVALUATED EQUIPMENT AND LINES WITH CO-WORKERS. NO VISIBLE ISSUES TO BE ADJUSTED WITH EQUIPMENT, UNKNOWN CAUSE OF MALFUNCTION. ICE PACKS APPLIED AND PATIENT CARE EQUIPMENT NOTIFIED THAT WE NEED A NEW GAYMAR MACHINE. NURSING FORCED TO UTILIZE COOLING BLANKET AND ICE PACKS TO KEEP PATIENT AT GOAL TEMP WHILE CONTINUING TO ATTEMPT TROUBLESHOOTING ON ONLY GAYMAR DEVICE AVAILABLE.
Patient problems: Alteration In Body Temperature
MAUDE report 8603274 ↗
Other Esophageal Thermal Regulation And Gastric Suctioning Device devices
- EnsoETM ECD02-AAdvanced Cooling Therapy, LLC · Esophageal Thermal Regulation And Gastric Suctioning Device2 reports
- EnsoETM ECD01-AAdvanced Cooling Therapy, LLC · Esophageal Thermal Regulation And Gastric Suctioning Device1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.