Microstream CO2 Extension 862393Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838021556), received between Jun 18, 2018 and Feb 27, 2026 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Failure to Calibrate

  IT WAS REPORTED DURING AN UNKNOWN EVENT, THE USER WAS UNABLE TO CALIBRATE THE CO2 DEVICE AND READINGS COULD NOT BE OBTAINED, WHICH WAS INDICATED BY AN INOP ALARM FOR 'EQUIPMENT MALFUNCTION'. THE MODULE WAS TAKEN TO THE BIOMED SHOP, WHERE THE SAME DEVICE BEHAVIOR WAS NOTED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24475095 ↗
• MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, WHEN THE STAFF WAS TRYING TO GATHER A CO2 READING, THEY WERE UNABLE TO DO SO. A PATIENT EVENT WAS REPORTED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461412 ↗
• InjuryNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ON (B)(6) 2022 AT AROUND 2 PM, THERE WAS A CO2 EQUIPMENT MALFUNCTION. A PATIENT HAD A HEART EPISODE WHILE CONNECTED TO THE DEVICE. THE M3015A DEVICE WAS SWAPPED OUT AND SENT FOR BENCH REPAIR. BENCH REPAIR DETERMINED THAT THE UNIT CONTAINS NON-SERVICEABLE PARTS AND THE ENTIRE UNIT WILL REQUIRE EXCHANGE.

  Patient problems: Unspecified Heart Problem

  MAUDE report 15751134 ↗
• InjuryJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE USER WAS REACHING FOR CORDS TO OBTAIN VITAL SIGNS, WHEN THE CO2 MONITOR FELL AND LANDED ON THE PATIENT¿S HEAD. THE USER IDENTIFIED 2 OF THE 4 SAFETY CLIPS THAT LOCK THE MODULE INTO PLACE WERE FOUND TO BE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 14999395 ↗
• DeathJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT CAUSED PHYSICAL DAMAGE TO THE DEVICE. AS A RESULT, THERE WAS A LOSS OF LIFE DUE TO DEVICE SHORTAGE AT THE CUSTOMER SITE. THE DEVICE WAS NOT IN CLINICAL USE AND A PATIENT DEATH WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13315302 ↗
• InjuryNov 19, 2021Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT WHEN PLUGGING IN A MICROSTREAM CO2 EXTENSION MODULE INTO A INTELLIVUE MP30 THE NURSE GOT SHOCKED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE. FURTHER DETAILS ABOUT THE NURSE, SUCH AS GENDER, AGE, HEIGHT AND WEIGHT HAD NOT BEEN MADE AVAILABLE. THE NURSE GOT SHOCKED.

  Patient problems: Electric Shock

  MAUDE report 12848271 ↗
• InjuryFeb 8, 2019Break; Device Fell

  THE CUSTOMER REPORTED THAT THERE WAS A BROKEN NOTCH ON THE CASE, AND AN X2 DEVICE FELL OUT OF THE M3015A. THE CUSTOMER WAS INJURED AS A RESULT OF THE DEVICE FALLING OUT OF THE CLIP. THE EXTENT OF THE INJURY WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Injury

  MAUDE report 8320037 ↗
• InjuryJun 18, 2018Computer Operating System Problem

  THE CUSTOMER REPORTED THAT DURING A PATIENT RESUSCITATION, THEY CONNECTED A MICROSTREAM CO2 EXTENSION TO THE MONITOR ATTACHED TO THE PATIENT. THE CONNECTION OF THE MICROSTREAM CO2 EXTENSION CAUSED THE MONITOR TO REBOOT AND THERE WAS A 1 MINUTE INTERRUPTION TO THE PATIENT MONITORING. THE PATIENT WAS BEING RESUSCITATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7610085 ↗