ECO Range - Maxi Series 62.002.0079.4244/711CRSARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315083297), received between Aug 13, 2020 and Sep 24, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING PRE-USE CHECK, CUSTOMER OBSERVED DAMAGE TO PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476269 ↗
• MalfunctionAug 19, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE SAMPLING PORT WAS FOUND BROKEN (DAMAGED) FROM THE BASE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262233 ↗
• MalfunctionMay 18, 2022Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE FILTER ABSORBED A LARGE AMOUNT OF WATER. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427709 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE SAMPLING CONNECTOR WAS FOUND BROKEN FROM THE BASE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514119 ↗
• MalfunctionAug 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED A SMITHS MEDICAL BREATHING/PORTEX RESPIRATORY FILTERS HEPA MALFUNCTIONED DURING AN OPERATION. THE CUSTOMER USED THE PRODUCT FROM 9:00 TO 17:30 FOR THE OPERATION, DURING WHICH INTRAVENOUS ANESTHESIA WAS GIVEN TO THE PATIENT AT FLOW RATE OF 3 LITERS PER MINUTE. SOME WATER DROPLETS WERE SEEN IN THE FILTER WHEN HE VISUALLY CHECKED IT DURING THE OPERATION. HOWEVER, AFTER THE OPERATION, RESPIRATORY RESISTANCE ROSE. SO HE REPLACED THE PRODUCT WITH ANOTHER ONE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10402395 ↗