ECO Range - Midi Series 62.002.0090.9064/711CRSARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315083303), received between Jul 3, 2019 and May 26, 2023 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY UPON VENTILATION USING THE HUMIDIFICATION (HME) FILTER. THE MEDICAL EMERGENCY TRANSPORT (MET) WAS CALLED, AND THE PATIENT WAS REOPENED AND HAD AN ICU ADMISSION. THE PRODUCT WAS DISPOSED/DISCARDED OF THE AFFECTED HME. THERE WAS NO INJURY, OR MEDICAL INTERVENTION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17009830 ↗
• DeathNov 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT "AN ACCIDENT OCCURRED WHEN THIS PRODUCT WAS USED IN COMBINATION WITH A HUMIDIFIER." THE PRODUCT WAS USED IN COMBINATION WITH A HEATING HUMIDIFIER AND A MEDICAL INCIDENT OCCURRED DURING THE USE OF IT. THIS IS AN INVESTIGATIVE INQUIRY FROM THE POLICE IN THE JURISDICTIONAL AREA, AND DETAILS ARE UNKNOWN. PRE-USE CHECK WAS NOT CLEAR. DISINFECTION AND STERILIZATION STATUS WERE UNKNOWN. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2022: THE PATIENT WAS IN THEIR 70S AND HAD A TRACHEOTOMY TUBE. ALSO, THE PATIENT WAS USING A HEATING HUMIDIFIER UNDER THE CONTROL OF AN ARTIFICIAL RESPIRATOR. AFTER THE PATIENT TOOK A BATH, THE BREATHING CIRCUIT WAS RE-CONNECTED, AND THEN, THE HEALTHCARE WORKER LEFT THE PATIENT'S SIDE. AFTER THAT, THE PATIENT WAS FOUND DEAD IN THE HOSPITAL ROOM. THE HEALTHCARE WORKER NOTICED AN HME FILTER WAS ATTACHED TO THE BREATHING CIRCUIT, WHICH HAD NOT BEEN USED BEFORE BATHING. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15748167 ↗
• MalfunctionSep 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PRODUCT WAS OCCLUDED DUE TO ABSORPTION OF EXCESSIVE AMOUNT OF WATER IN ITS HEAT AND MOISTURE EXCHANGE(HME) FILTER. THE FILTER NEEDED TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427010 ↗
• InjuryJul 3, 2019Output Problem; Output Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL GAS PORT WAS REPLACED FOLLOWING A HIGH PRESSURE ALARM SOUNDING ON THE RESPIRATORY. IT WAS REPORTED PATIENT COULD NOT BREATHE AND CYANOSIS APPEARED AT THE TIME OF THE ALARM. WHEN THE PRODUCT WAS DISCONNECTED, THE RESPIRATORY CONDITION IMPROVED, BUT WHEN THE PRODUCT WAS CONNECTED AGAIN, BREATHING DETERIORATED ONCE MORE. PRODUCT HAD BEEN USED EVERY DAY FOR A WEEK PRIOR TO THIS INCIDENT, DURING WHICH THE PATIENT HAD COMPLAINED OF RESPIRATORY PROBLEMS SEVERAL TIMES. NO FURTHER ADVERSE EVENTS REPORTED.

  Patient problems: Cyanosis; Respiratory Distress

  MAUDE report 8757557 ↗