Microstream PM35MN02Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521551596), received between Mar 27, 2019 and Jan 20, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (14 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Device Alarm System

  IT WAS REPORTED THAT THE SPO2 ALARM ON THE DEVICE DID NOT ACTIVATE WHEN OXYGEN SATURATION REACHED ITS LOWER LIMITS DURING PRE-OPERATIVE PREPARATION. THE DEVICE ALARM FAILED WHEN THE ISSUE OCCURRED. THE DEVICE WAS TESTED BEFORE USE, AND THE LOWER AND HIGH ALARMS WERE UPDATED. THERE WAS AN VISUAL BUT NO AUDIBLE ALARM. TROUBLESHOOTING STEPS INCLUDED TESTING THE DEVICE AND UPDATING ALARM SETTINGS, AS WELL AS SWAPPING TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116288 ↗
• MalfunctionSep 10, 2025Device Alarm System; Charging Problem; Device Alarm System; Charging Problem

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE DID NOT TAKE CHARGE EVEN AFTER THE BATTERY WAS SWAPPED. NO ALARM WAS PRESENTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013355 ↗
• MalfunctionSep 3, 2025Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE MONITOR'S BACKLIGHT WAS NOT WORKING. NO TROUBLESHOOTING STEPS WERE DONE TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956892 ↗
• MalfunctionSep 3, 2025Device Alarm System; Failure of Device to Self-Test; Device Alarm System; Failure of Device to Self-Test

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE OF THE MONITOR, A DISPLAYED MESSAGE INDICATING SFM DATA INTEGRITY FAILED AND FAILED TO COMPLETE THE POWER ON SELF TEST (POST). THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950089 ↗
• MalfunctionAug 20, 2025Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test; Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE UNIT DISPLAYED THE MESSAGE "POSTOS: SFM DATA INTEGRITY FAILED, LAUNCHING UPGRADE" AND DID NOT COMPLETE THE POWER ON SELF TEST (POST) DURING PRE-OPERATIVE PREPARATION. THERE WAS NO ALARM HEARD WHEN THE ISSUE OCCURRED.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850514 ↗
• MalfunctionAug 1, 2025Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test; Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE UNIT DISPLAYED THE MESSAGE: 'POSTOS: SFM DATA INTEGRITY FAILED, LAUNCHING UPGRADE,' AND DID NOT COMPLETE THE POWER-ON SELF-TEST (POST) DURING PRE-OPERATIVE PREPARATION FOR USE. ADDITIONALLY, THERE WAS NO AUDIBLE ALARM WHEN THE MALFUNCTION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22691154 ↗
• MalfunctionMay 30, 2025Device Alarm System; High Readings; Device Alarm System; High Readings

  IT WAS REPORTED THAT DURING USE, THE UNIT GAVE REALLY HIGH READINGS, AND RANDOM ALARMS WERE GOING OFF, BUT THE CUSTOMER DID NOT KNOW WHAT THOSE ALARMS WERE FOR. THE UNIT WAS SWAPPED WITH ANOTHER ONE WHICH WORKED JUST FINE. THE ISSUE WAS ISOLATED TO THE REPORTED UNIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115052 ↗
• MalfunctionMay 8, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE READINGS INDICATED A VALUE OF 2 ON THE PATIENT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21985403 ↗
• MalfunctionMar 19, 2025Image Display Error/Artifact; Incorrect Measurement; Unable to Obtain Readings; Failure to Calibrate; Image Display Error/Artifact; Incorrect Measurement; Unable to Obtain Readings; Failure to Calibrate

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE, THE UNIT FAILED CO2 CALIBRATION AFTER COMPLETING GAS INTAKE AND PRODUCED ERRORS INDICATING NO GAS AND WRONG GAS. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE UNIT, FOLLOWING THE CO2 CALIBRATION PROCEDURE, AND USING THE RECOMMENDED GAS KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643802 ↗
• MalfunctionJan 15, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT WAS NOT READING CO2 CORRECTLY. THE USER TRIED TO SWAPPED OUT LINES AND TRIED TO GET CO2 READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157267 ↗
• MalfunctionJan 15, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT WAS NOT READING CO2 CORRECTLY. THE USER TRIED TO SWAPPED OUT LINES AND TRIED TO GET CO2 READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157170 ↗
• MalfunctionJan 10, 2025Use of Device Problem; Defective Component; Low Readings; Use of Device Problem; Defective Component; Low Readings

  IT WAS REPORTED THAT DURING SERVICING, THE DEVICE EXPERIENCED SEVERAL ISSUES, INCLUDING A VERY SLOW KEYPAD RESPONSE, CO2 ASSEMBLY OUTPUT BELOW THE REQUIRED FLOW AND A CO2 PUMP ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129981 ↗
• MalfunctionNov 8, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT GAVE LOW ETCO2 READINGS OF ABOUT MID-20S INSTEAD OF THE NORMAL RANGE OF 30-40 MM HG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645957 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Failure to Run on Battery; Incorrect Measurement; Failure to Run on Battery

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A BATTERY ERROR AND WAVEFORMS WERE NOT SHOWING UP CORRECTLY. THE CUSTOMER WAS ADVISED THAT THE BATTERY NEEDED TO BE CHARGED AND THE EXTERNAL BATTERY MAY NEED TO BE REPLACED. FOR THE WAVEFORMS, IT WAS ADVISED THAT THE FACILITY COULD CHANGE THE DISPLAY BACKGROUNDS, AND IF THE WAVEFORMS WERE INCORRECT, ANY ERRORS SHOULD BE CHECKED AS WELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627443 ↗
• MalfunctionNov 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD LOW PUMP OUTPUT. THE DEVICE WAS RECALIBRATED. THE ISSUE WAS ISOLATED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621382 ↗
• MalfunctionOct 30, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S ETCO2 VALUE WAS ABNORMALLY HIGH, SUCH AS 150 IN COMPARISON WITH PATIENT STATUS. THERE WAS NO PATIENT HARM.

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

  MAUDE report 20571974 ↗
• MalfunctionOct 25, 2024Image Display Error/Artifact; Incorrect Measurement; Image Display Error/Artifact; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE MONITOR HAD A SYSTEM RED BACKLIGHT WHICH INDICATED AN ERROR, AND INCONSISTENT WAVEFORM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537278 ↗
• MalfunctionOct 17, 2024Device Alarm System; Incorrect Measurement; Low Readings; Device Alarm System; Incorrect Measurement; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE MONITOR HAD INCONSISTENT READINGS. IT WOULD READ 9 AND ANOTHER MACHINE WOULD READ 25 ON SAME PATIENT. THERE WAS NO PATIENT OUTCOME.

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

  MAUDE report 20470375 ↗
• MalfunctionOct 17, 2024Device Alarm System; Incorrect Measurement; Low Readings; Device Alarm System; Incorrect Measurement; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE MONITOR HAD INCONSISTENT READINGS. IT WOULD READ 9 AND ANOTHER MACHINE OF THE SAME TYPE WOULD READ 25 ON SAME PATIENT. THE READINGS WERE LOWER THAN EXPECTED. THERE WAS NO AUDIBLE OR VISUAL ALARM. THERE WAS NO PATIENT HARM.

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

  MAUDE report 20470171 ↗
• MalfunctionOct 2, 2024Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, MONITOR POWER CHARGING CORD WAS COMBUSTED AND CAUGHT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355075 ↗
• MalfunctionSep 23, 2024Image Display Error/Artifact; Failure to Calibrate; High Readings; Image Display Error/Artifact; Failure to Calibrate; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE PRODUCED HIGH CO2 READINGS ON A PATIENT. CALIBRATION WAS ATTEMPTED BUT THE DEVICE FAILED AND PRODUCED "WRONG GAS AND UNSTABLE GAS" ERROR MESSAGES. THE DEVICE WAS POWER CYCLED AND STANDARD CALIBRATION PROCEDURE WASFOLLOWED. THE FILTER LINE COULD NOT BE CONFIRMED IF SWAPPED FOR THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279562 ↗
• MalfunctionSep 2, 2024Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE ETCO2 VALUE WAS STRANGE OR WEIRD WITH VALUE 150MMHG. POWER WAS RESTARTED AND FILTER LINE WAS REPLACED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20119082 ↗
• MalfunctionApr 10, 2024High Readings; Insufficient Device Problem Information; High Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE UNIT WAS USED DURING CARDIAC ARREST, AND THE READINGS WERE ERRATIC. FROM THE NORMAL READING OF ETCO2 TO 99, THEN BACK TO 40, JUMPING UP, IT HIT ZERO (0). NORMAL RANGE READINGS WERE LOWER THAN 99 AND TYPICALLY 20 TO 50. THERE WAS NO PATIENT HARM ASCRIBED TO THE MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081108 ↗
• MalfunctionMar 27, 2024Device Alarm System; Unable to Obtain Readings; Device Damaged Prior to Use; Device Alarm System; Unable to Obtain Readings; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT COULD NOT MEASURE ETCO2, HAD A BROKEN CONNECTOR PART, AND THERE WERE NO AUDIBLE AND VISUAL ALARMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986267 ↗
• MalfunctionFeb 15, 2024Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD BLINKING YELLOW LIGHT BUT HAD NO ALARM. WHEN UNIT BOOTED UP, THE LIGHTS FLASHED BUT THERE WAS NO SPEAKER SOUND. THIS WAS IN DIRECT CONTRADICTION TO THE MANUAL STATED LIGHTS WOULD FLASH AND ALARM WOULD BRIEFLY SOUND UPON STARTUP. THE USER ALSO CHECKED WITH A SIMULATOR AND THERE WAS NO SOUND ALARM WHEN THE UNIT WAS IN SPO2 ALARM MODE. TESTING OCCURRED USING A SENSOR SIMULATOR WHICH OPERATED AT EITHER SPO2 READINGS OF 90 OR 75 TO SIMULATE NORMAL VS ALARM CONDITIONS. PRESUMABLY THE SETTINGS WERE SUCH THAT 75 WOULD TRIGGER AN ALARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712192 ↗