EnsoETM ECD02-A (UDI 00857915006050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857915006050), received between Dec 15, 2017 and Oct 10, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT ARRIVED AT THE NEURO ICU WITH SEVERE CRANIOFACIAL TRAUMA DESCRIBED AS OCCIPITAL BONE FRACTURE, BILATERAL SPHENOID FRACTURE, FIRST MAXILLARY INCISOR FRACTURE, TEMPORAL BONE FRACTURE EXTENDING INTO TEMPOROMANDIBULAR JOINT, AND NASAL BONE FRACTURES. THESE INJURIES WERE CAUSED BY JUMPING OUT OF A CAR TRAVELING APPROXIMATELY 50 MPH. THE PATIENT WAS INITIALLY INTUBATED WITH AN ENDOTRACHEAL TUBE AND A STANDARD OROGASTRIC TUBE WAS PLACED. A NURSE SUBSEQUENTLY ATTEMPTED TO PLACE THE ENSOETM WITHOUT REMOVING THE OROGASTRIC TUBE. THE NURSE EXPERIENCED SOME DIFFICULTY PLACING THE ENSOETM, BUT WAS ABLE TO SUCCESSFULLY PLACE THE DEVICE. AFTER SEVERAL HOURS, THE NEURO ICU STAFF NOTICED CREPITUS IN THE NECK AREA. UPON INSPECTION, THEY DISCOVERED AN INJURY, DESCRIBED AS A "TEAR" TO THE ESOPHAGUS. MEDICAL INTERVENTION WAS REQUIRED TO CLIP THE TEAR. THE PATIENT SURVIVED THE INCIDENT AND WAS LATER DISCHARGED FROM THE NEURO ICU.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 7953505 ↗
• InjuryDec 15, 2017Fluid/Blood Leak; Fluid/Blood Leak

  BACKGROUND: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A KIDNEY TRANSPLANT AND HAD RECEIVED DIALYSIS THAT DAY. THE PATIENT WAS ADMINISTERED VANCOMYCIN PRE-SURGERY DUE TO IDENTIFIED BACTEREMIA IN THE DONOR KIDNEY. THE PATIENT HAD AN ANAPHYLACTIC REACTION TO THE VANCOMYCIN THAT WAS RECOGNIZED IMMEDIATELY. THE CODE TEAM RESPONDED AND WAS AT THE BEDSIDE WHEN THE PATIENT WENT INTO PEA (PULSELESS ELECTRIC ACTIVITY) ARREST WITH 45 MINUTES OF CPR (CARDIOPULMONARY RESUSCITATION) BEFORE RETURN OF SPONTANEOUS CIRCULATION. THE PATIENT WAS INITIALLY INTUBATED WITH AN LMA (LARYNGEAL MASK AIRWAY), WHICH WAS THEN SWITCHED OUT FOR AN ENDOTRACHEAL TUBE. INCIDENT: FOLLOWING RETURN OF SPONTANEOUS CIRCULATION, THE ENSOETM WAS PLACED AT 0200 ON (B)(6) 2017. DURING THE COURSE OF TREATMENT, THE END USER RECEIVED AT LEAST 3 (BUT POSSIBLY 4) LOW WATER ALARMS FROM THE EXTERNAL HEAT EXCHANGER USED IN CONJUNCTION WITH THE ENSOETM. THE END USER REFILLED THE WATER RESERVOIR AT LEAST 2 (BUT POSSIBLY 3) TIMES WITHOUT REMOVING AND EXAMINING THE ENSOETM. 400 ML OF GASTRIC CONTENTS WERE SUCTIONED FROM THE PATIENT'S STOMACH AT 1200. THE ENSOETM WAS REMOVED AT 1300, AND A LEAK WAS DISCOVERED ON THE MAIN TUBE NEAR THE

  Patient problems: Electrolyte Imbalance

  MAUDE report 7123571 ↗