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EnsoETM ECD04-ARecalls & reported problems

Advanced Cooling Therapy, LLC · The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857915006227), received between Sep 11, 2019 and Sep 11, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1

Patient problems

  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 11, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    AN END USER REPORTED DISCOVERING A TEAR IN THE PATIENT'S STOMACH FOLLOWING PLACEMENT OF THE ENSOETM. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT IN CARDIAC ARREST ON (B)(6) 2019. THE PATIENT HAD BEEN ON A DANCE FLOOR WHEN HE COLLAPSED. HE RECEIVED BYSTANDER CARDIOPULMONARY RESUSCITATION (CPR) AND RECEIVED TWO SHOCKS FROM AN AUTOMATIC EXTERNAL DEFIBRILLATOR. PARAMEDICS ARRIVED AND PERFORMED EXTENDED CPR, WITH A TOTAL OF SIX ROUNDS OF EPINEPHRINE ADMINISTRATION, A SINGLE DOSE OF 300 MG OF AMIODARONE, AND A TOTAL OF SIX ADDITIONAL SHOCKS. THE PATIENT RECEIVED A RETURN OF SPONTANEOUS CIRCULATION AND WAS TRANSFERRED TO THE LOCAL EMERGENCY DEPARTMENT. IN THE LOCAL EMERGENCY DEPARTMENT, THE PATIENT WAS STARTED ON A CONTINUOUS DRIP OF AMIODARONE, A CENTRAL LINE WAS PLACED, A NASOGASTRIC TUBE WAS PLACED, AND A VASOACTIVE AGENT (LEVOPHED) WAS INITIATED TO PROVIDE BLOOD PRESSURE SUPPORT AND TREAT HYPOTENSION. THE PATIENT WAS THEN TRANSFERRED TO A TERTIARY CARE CENTER FOR A HIGHER LEVEL OF CARE, ARRIVING AT THE TERTIARY CARE HOSPITAL ON (B)(6) 2019 AT 11:30PM. THE PATIENT WAS NOTED TO HAVE SPONTANEOUS MOVEMENTS OF BILATERAL UPPER EXTREMITIES, BUT WOULD NOT RESPOND TO COMMANDS. THE PATIEN

    Patient problems: Laceration(s)

    MAUDE report 8995055 ↗

Other Lubricant, Patient devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.