SMARTDOSE CTOX-MN02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814470020075), received between May 31, 2017 and May 31, 2017 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMay 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONSERVER WAS NOT PRODUCING SUFFICIENT OXYGEN. ADDITIONAL INFORMATION OBTAINED FROM THE DELIVERY DRIVER WHO SPOKE WITH THE PATIENT'S CAREGIVER IS AS FOLLOWS: THE CAREGIVER STATED THAT SHE WALKED INTO THE ROOM AND FOUND THE PATIENT HAD A SYNCOPAL EPISODE. THE CAREGIVER STATED THAT ALL THE LIGHTS ON THE CONSERVER WERE ON AND THE DEVICE WAS IN THE CONSERVE MODE. SHE STATED THAT SHE CHANGED THE DEVICE TO CONTINOUS FLOW AND THE PATIENT REGAINED CONSCIOUSNESS. THERE WAS NO REPORTED DEVICE MALFUNCTION AND IT COULD NOT BE DETERMINED IF THE PATIENT REGAINED CONSCIOUSNESS BECAUSE THE DEVICE WAS SWITCHED TO CONTINOUS FLOW OR IF THE SYMPTOMS RESOLVED SPONTANEOUSLY. THERE WAS NO ADDITIONAL REPORTED MEDICAL INTERVENTIONS PERFORMED AND THE PATIENT DID NOT SEEK MEDICAL ATTENTION FOR THE ISSUE DESCRIBED. IT WAS NOTED BY THE DELIVERY DRIVER THAT THE TAG WITH THE SERIAL NUMBER HAD FADED AS IF A CHEMICAL CLEANING AGENT WAS USED ON THE DEVICE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6603063 ↗