Microstream CS08651-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521551480), received between Dec 11, 2017 and Jan 26, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Data Problem” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Device Alarm System; Failure to Analyze Signal; Data Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT¿S SPO2 READING WAS FOUND DROPPING. ALSO, THE UNIT WOULD NOT HOLD DATE AND TIME. THERE WAS NO AUDIBLE OR VISUAL ALARM WHEN THE ISSUES OCCURRED. THE CUSTOMER SWAPPED SEVERAL CABLES AND SENSORS, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177510 ↗
• MalfunctionDec 30, 2025Device Alarm System; Image Display Error/Artifact; Data Problem; Device Alarm System; Image Display Error/Artifact; Data Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN SPO2 ERROR, WAS NOT HOLDING TIME AND THE CONFIRMED EQUIVALENT TO DATE IS INVALID. THERE WAS NO AUDIBLE OR VISUAL ALARM PRESENTED. SWAPPED TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922416 ↗
• MalfunctionOct 29, 2025Device Alarm System; Failure to Run on Battery; Data Problem; Device Alarm System; Failure to Run on Battery; Data Problem

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, BATTERY EXPIRATION WAS IDENTIFIED. THE DEVICE WOULD NOT HOLD THE DATE AND TIME. NO AUDIBLE VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421026 ↗
• MalfunctionOct 29, 2025Device Alarm System; Failure to Run on Battery; Data Problem; Device Alarm System; Failure to Run on Battery; Data Problem

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE BATTERY WAS DEPLETED. THE DEVICE WOULD NOT HOLD THE DATE AND TIME. NO AUDIBLE VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421025 ↗
• MalfunctionOct 29, 2025Device Alarm System; Failure to Run on Battery; Data Problem; Device Alarm System; Failure to Run on Battery; Data Problem

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE BATTERY WAS DEPLETED. THE DEVICE WOULD NOT HOLD THE DATE AND TIME. NO AUDIBLE VISUAL ALARM WAS PRESENTED FOR THE FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421006 ↗
• MalfunctionMar 25, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING TESTING/MAINTENANCE, THERE WERE LOW READINGS ON THE SYSTEM COMPARED TO THE CORRECT READINGS ON THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691808 ↗
• MalfunctionMar 3, 2025High Readings; Data Problem; High Readings; Data Problem

  IT WAS REPORTED THAT DOWNLOADING READINGS FROM THE UNIT TO OTHER SYSTEM WAS CORRECT BUT HIGH READINGS BY 8 ON THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510076 ↗
• MalfunctionFeb 18, 2025Device Damaged Prior to Use; Temperature Problem; Device Damaged Prior to Use; Temperature Problem

  ACCORDING TO THE REPORTER, THE PRODUCT HAD BROKEN PRONGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402488 ↗
• MalfunctionJan 17, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT NORMAL WAVEFORMS AND VALUES WERE OBSERVED INITIALLY. AFTER 10-15 MINUTES, DISTORTED WAVEFORMS AND INCORRECT VALUES APPEARED, WITH NO CHANGE IN PATIENT BREATHING. THE SYSTEM¿S DEFAULT MONITOR SETTINGS WERE BEING USED, WITH TWO EXCEPTIONS: THE NURSE CALL WAS ENABLED, AND THE IPI ALARM WAS ENABLED. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 21178189 ↗
• MalfunctionNov 28, 2022Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS SHOWING A GREEN LED LIGHT, BUT THE MONITOR WOULD NOT TURN ON. AND ONE TIME, WHEN THE UNIT WAS POWERED ON IT BEGAN TO SMOKE HAVING A BURNING SMELL. IT WAS POWER CYCLED AND THE BATTERY WAS SWAPPED FOR TROUBLE SHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870196 ↗
• MalfunctionFeb 4, 2022Failure to Power Up; Temperature Problem; Noise, Audible; Failure to Power Up; Temperature Problem; Noise, Audible

  ACCORDING TO THE REPORTER, THE PRODUCT WOULD NOT TURN OFF PRIOR TO USE. IT WOULD GET WARM WITHIN A FEW MINUTES AND HAD A SPEAKER AUDIO ISSUE. THE BATTERY WAS SWAPPED WITH A NEW ONE WITH NO CHANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453724 ↗
• MalfunctionOct 7, 2021Failure to Run on Battery; Failure to Power Up; Temperature Problem; Failure to Run on Battery; Failure to Power Up; Temperature Problem

  ACCORDING TO THE REPORTER, THE UNIT BATTERY ICON WAS NOT SHOWING IT WAS RUNNING. BATTERY WAS TURNED OFF AND NOTICED BURNING SMELL. THE DEVICE WOULDN'T POWER ON EVEN THOUGH THE AC INDICATOR WAS LIT GREEN. UNIT WAS POWER CYCLED A FEW TIMES AND WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590181 ↗
• MalfunctionAug 9, 2021Display or Visual Feedback Problem; Temperature Problem; Display or Visual Feedback Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A HOT BURNING SMELL COMING OUT OF UNIT AND SCREEN DID NOT COME ON. IT WAS REPORTED THAT THERE WAS NO BURN AND ONLY HOT SMELL. REPLACED THE BATTERY TO TROUBLESHOOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292976 ↗
• MalfunctionAug 3, 2021Failure to Analyze Signal; Communication or Transmission Problem; Failure to Analyze Signal; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO GET ODI READINGS AND DOWNLOAD SOFTWARE FROM USB NOTING AN ERROR. TRIED DOWNLOADING NEW SOFTWARE BUT STILL DID NOT HAVE OPTION. FOUND NO AUDIO IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270629 ↗
• MalfunctionMay 19, 2020Device Alarm System; Failure to Power Up; Filtration Problem; Device Alarm System; Failure to Power Up; Filtration Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WHICH IS USED FOR NURSE'S CALL HAD AN UNWAVERING SPO2 ALARM WHEN THE PATIENT DESATURATED. THE DEVICE WAS FOUND TO BE NOT WORKING, TURNED ON AND OFF AND GENERATED AN ALARM OF FILTER LINE NOT CONNECTED. THE HOSPITAL CANNOT VERIFY THAT THE DEVICE IN THIS REPORT HAD THE NURSE CALL FEATURE ENABLED AND WAS TURNED ON. ANY NURSE CALL SETTING WERE LOST WHEN THE BIOMED DEPARTMENT USED THIS DEVICE AFTER IT WAS OBTAINED AND ALL INFORMATION FROM THE EVENT WAS ERASED. THE HOSPITAL REPORTED THE PATIENT'S DEATH IS COVID19 RELATED AND THE DEVICE WAS NOT RELATED TO THE DEATH IN ANY WAY.

  Patient problems: Death

  MAUDE report 10068534 ↗
• MalfunctionJan 6, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD SMOKE OBSERVED AND SMELL OF BURNING WIRE INSULATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9556024 ↗
• MalfunctionMay 24, 2019Computer Software Problem; Noise, Audible; Computer Software Problem; Noise, Audible

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO AUDIO. IT WAS STATED THAT WHEN THE DEVICE WAS TURNED ON THERE ARE VISUAL ALARMS BUT NO BEEP OR ALARMS INITIATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8640746 ↗
• MalfunctionDec 27, 2018High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD A HIGH PULSE READINGS. THE PATIENT WAS SLIGHTLY TACHYCARDIC RUNNING ABOUT 120 AND PULSE RATE JUMPED UP TO 235. THE NURSE PUT TELEMETRY ON PATIENT AND NURSE NOTICED THAT THERE WAS DIFFERENCE BETWEEN TELEMETRY READING AND THE UNIT'S PULSE RATE. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS REPORTED CONDITION OF THE DEVICE WOULD NOT CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF THE MALFUNCTION WAS TO RECUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199610 ↗
• MalfunctionAug 8, 2018No Audible Alarm; Break; Display or Visual Feedback Problem; Material Integrity Problem; Display or Visual Feedback Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD SCREEN DAMAGED. THE CUSTOMER UNIT HAD NO AUDIBLE ALARM. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7763824 ↗
• InjuryMay 22, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ACCORDING TO THE REPORTER, THE DEVICE FLASHED REQUIRED CALIBRATION AND DID NOT WORK PROPERLY. THE CUSTOMER INDICATED THAT THE PATIENT WAS HOSPITALIZED OVER THE WEEKEND DUE TO MALFUNCTION.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 7534869 ↗
• MalfunctionApr 18, 2018Device Emits Odor; Device Emits Odor

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE HAD A BURNING ELECTRICAL SMELL AND BATTERY ICON WAS IN RED. THE CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7441036 ↗
• MalfunctionApr 5, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING ANALYSIS OF THE UNIT, IT WAS OBSERVED THAT THERE WAS A BURNING SMELL AND WHITE SMOKE OBSERVED AT THE BOTTOM OF THE UNIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7400160 ↗
• MalfunctionDec 11, 2017Smoking; Smoking

  MEDTRONIC RECEIVE A REPORT THAT A SMALL PUFF OF SMOKE WAS OBSERVED AT THE BOTTOM OF THE UNIT AND THEN THE UNIT DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7105880 ↗