Microstream CS08651-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521722927), received between Oct 18, 2018 and Jan 21, 2026 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K123690); they may or may not involve this specific model.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Device Alarm System; Failure to Calibrate

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE WOULD NOT CALIBRATE AND FAILED THE POWER ON SELF TEST (POST). NO AUDIBLE OR VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140477 ↗
• MalfunctionJan 21, 2026Device Alarm System; Failure to Calibrate

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE FAILED CALIBRATION. THERE WAS NO AUDIBLE OR VISUAL ALARM PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140377 ↗
• MalfunctionMay 1, 2025Incorrect Measurement; Defective Component; Incorrect Measurement; Defective Component

  IT WAS REPORTED THAT THE UNIT FAILED THE LEAK TEST AND DID NOT READ CO2 CORRECTLY. THE ISSUE WAS ISOLATED TO THE REPORTED UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944011 ↗
• MalfunctionMay 1, 2025Incorrect Measurement; Defective Component; Incorrect Measurement; Defective Component

  IT WAS REPORTED THAT THE DEVICE FAILED A LEAK TEST AND THE CO2 READINGS WERE INCORRECT. THE ISSUE WAS FIRST OBSERVED DURING PRE-OPERATIVE PREPARATIONS. TROUBLESHOOTING STEPS INCLUDED SWAPPING TO ISOLATE THE PROBLEM, BUT THE DEVICE WAS UNABLE TO PASS THE LEAK TEST AND CO2 READINGS REMAINED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943717 ↗
• MalfunctionMar 19, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE, THERE WAS NO AUDIO COMING FROM THE SPEAKER OF THE MONITOR. TROUBLESHOOTING STEPS INCLUDED ENSURING ALL CONNECTIONS WERE SECURE AND POWER CYCLING THE DEVICE, WHICH RESULTED IN A CLICKING SOUND BUT NO OTHER AUDIO. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643702 ↗
• MalfunctionMar 2, 2025Failure to Analyze Signal; Failure to Analyze Signal

  IT WAS REPORTED THAT DURING PREPARATION FOR USE, A DEVICE MALFUNCTION OCCURRED DUE TO AUTO ZEROING EVERY TWO MINUTES, WHICH RESULTED IN A DELAY OF THE PROCEDURE/SURGERY. TROUBLESHOOTING ISOLATED THE ISSUE TO THE DEVICE ITSELF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501289 ↗
• MalfunctionJan 8, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A DEVICE WAS NOT ALARMING DURING THE PRE-OPERATIVE PHASE WHILE PREPARING FOR USE. THE END USER NOTED THE LACK OF ALARMS, AND COULD NOT IDENTIFY ANY OTHER ISSUES WITH THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT OR COMPLICATIONS REPORTED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106180 ↗
• MalfunctionNov 21, 2024Failure to Calibrate; High Readings; Failure to Calibrate; High Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A HIGH CO2 READING AND WOULD NOT CALIBRATE. ATTEMPTED TO RECALL AND FAILED. SWAPPED TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754171 ↗
• MalfunctionNov 6, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD HIGH READINGS NOTED WITH THE CO2 CALIBRATION, CAL CHECK AND CALIBRATION PERFORM MED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622607 ↗
• MalfunctionOct 15, 2024Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE UNIT HAD NO SOUND WHEN TURNED ON AND THERE WAS NOT SOUND DURING POST. THE BATTERY WAS RECHARGED AND UNIT WAS NOW WORKING PROPERLY AND MAKING POST SOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450466 ↗
• MalfunctionMar 8, 2023Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT DID NOT POWER ON COMPLETELY, ONLY THE LIGHTS TURNED ON, AND IT PRODUCED AN INTERNAL BURNING ODOR. THE CUSTOMER POWERED OFF THE UNIT. IT WAS POWER CYCLED AS A TROUBLESHOOTING STEP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16502023 ↗
• MalfunctionMay 4, 2022Device Alarm System; Failure to Power Up; Temperature Problem; Device Alarm System; Failure to Power Up; Temperature Problem

  ACCORDING TO THE REPORTER, THE UNIT WOULD NOT TURN ON AND WAS SMOKING. THE UNIT WAS POWER CYCLED AND BATTERIES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282232 ↗
• MalfunctionOct 13, 2021Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE UNIT'S ALARM DID NOT SOUND. UNIT WAS POWER CYCLED AND BATTERIES WERE REPLACED TO ISOLATE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628828 ↗
• MalfunctionMay 27, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A RESIDUAL SMELL AND SMOKED WHEN PLUGGED IN. THEY PLUGGED IT IN AGAIN AND THE UNIT WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10091670 ↗
• DeathOct 18, 2018Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT ALARM. THE CUSTOMER REPORTED THAT THE DEVICE ALARMED THROUGHOUT THE NIGHT, BUT WHEN THE PATIENT WAS FOUND EXPIRED, THE MONITOR HAD NOT BEEN ALARMING. IT WAS REPORTED THAT THE DEVICE WAS CONNECTED TO ANOTHER SYSTEM VIA WIFI, WHEREIN THEY NEED TO SEE IF THERE IS AN INTERMITTENT WIFI CONNECTION ISSUE.

  Patient problems: Death

  MAUDE report 7981436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123690. One submission often covers many models, so check the product and lot details in each record.

• Z-1577-2016 · Apr 13, 2016 · Terminated
  Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostrea