IntelliVue Microstream ExtensionRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00884838083585), received between Feb 6, 2019 and May 19, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Fell” (4 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MICROSTREAM EXTENSION INDICATING THE DEVICE HAD INACCURATELY HIGH CARDIAC OUTPUTS. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221562 ↗
• MalfunctionApr 30, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MICROSTREAM EXTENSION DEVICE INDICATING THAT DURING PATIENT CONTINUOUS MONITORING, THE MICROSTREAM ETCO2 MEASUREMENT EXTENSION MODULE STOPPED WITHOUT TRIGGERING AN INOPERATIVE (INOP) ALARM. THE SAMPLE LINE HAS BEEN REPLACED, BUT THE ISSUE WAS STILL PRESENT. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044690 ↗
• MalfunctionMar 26, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE MICRO STREAM'S IBP WAS NOT ACCURATE AS THE DEVICE WAS GIVING MEASUREMENTS LOWER THAN NORMAL. AT 200/150 THE UNIT GAVE A READING OF 180/130. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696102 ↗
• MalfunctionFeb 27, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MICROSTREAM EXTENSION INDICATING THAT THE INVASIVE BLOOD PRESSURE HAS ABNORMAL VALUES REACHING UP TO 200. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475097 ↗
• MalfunctionFeb 20, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON INTELLIVUE MICROSTREAM EXTENSION INDICATING THAT THE PRESSURE BOARD FAILED TO GIVE CONSISTENT ACCURATE INFORMATION. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401830 ↗
• MalfunctionJan 26, 2026Incorrect Measurement

  DURING EVALUATION AT BENCH REPAIR IT WAS FOUND THAT THE DEVICE FAILED TO TAKE ACCURATE READINGS. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176256 ↗
• MalfunctionDec 11, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MICROSTREAM EXTENSION INDICATING THAT THE CUSTOMER WAS HAVING ISSUES WITH THE CAPTURES OF INVASIVE BLOOD PRESSURES; OFTEN THE PRESSURES NOT CAPTURING AND OR ARE HIGH IN VALUES. THE SITE HAS SWAPPED THE TRANSDUCERS AND ADJUSTED THE ZERO LINES, BUT THE PROBLEM STILL PERSISTS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782938 ↗
• InjuryNov 20, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THE ETCO2 TUBING REQUIRED CHANGING EVERY 3-5 HOURS DUE TO OBSTRUCTION. THIS PREMATURE INFANT WAS ON A HUMIDIFIED VENTILATOR CIRCUIT IN A HUMIDIFIED ISOLETTE AND REQUIRED CO2 TUBING CHANGES EVERY 3-5 HOURS. THE TUBING WAS INTEGRATED INTO THE VENTILATOR CIRCUIT BETWEEN THE VENTILATOR AND BALLARD SUCTION. THE CLINICAL AUDIT LOGS WERE REVIEWED BY THE REMOTE SERVICE ENGINEER, REVEALING CO2 OCCLUSION TECHNICAL INOP ALARMS AT 12 HOURS AND 10 HOURS. THE TUBING SET UP WAS REVIEWED, REVEALING NO ANOMALIES IN THE WAY THE CIRCUIT WAS MANAGED. THE ETCO2 MODULE WAS WORKING FINE FOR A FEW HOURS BUT THEN IT WOULD STOP PICKING UP THE MEASUREMENT, SO THE SENSOR WAS CHANGED EVERY 2-3 HOURS. IT WAS NOTED THERE WAS NO CONDENSATION IN THE TUBING AND NO AIR LEAK. THE CUSTOMER COULD NOT DETERMINE WHAT THE CAUSE OF THE ISSUE WAS, THOUGH THEY SUSPECTED THE MODULE COULD BE A CAUSE. IT WAS ALSO CLARIFIED THAT BREAKING INTO THE CIRCUIT MULTIPLE TIMES TO CHANGE OUT SENSORS IS AN INFECTION RISK AND THE NURSE INDICATED '...THIS PATIENT NOW HAS A POSITIVE TRACH ASPIRATE AND IS SICK'. THE CUSTOMER SWITCHED TO TRANSCUTANEOUS MEASUREMENT OF CO2 DUE TO THE REPORTED ISSUE. FURTHER CLARIFICATION WAS RECE

  Patient problems: Bacterial Infection

  MAUDE report 23609428 ↗
• MalfunctionSep 17, 2025No Device Output; No Device Output

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE MICROSTREAM EXTENSION. IT WAS REPORTED THE SPO2 MEASUREMENT DISPLAYED 0%, THOUGH THE VENTILATED PATIENT WAS ON 100% OXYGEN. A DYNAMP WAS CONNECTED TO THE PATIENT, DISPLAYING SPO2 OF 97%. THE CUSTOMER INDICATED THERE WAS SEVERE HARM; HOWEVER, NO ADDITIONAL DETAILS OF THE ALLEGED HARM HAVE BEEN PROVIDED. IT WAS INDICATED BY THE CUSTOMER 'PEDIATRIC PATIENT WAS INTUBATED AND THE MONITOR SHOWED SATS OF 0% DESPITE A VERY GOOD PLETH TRACE, BP, AND HR. WE WERE GIVING 100% OXYGEN, BUT THE MONITOR STILL SAID 0%. WE ALSO THEN LOST OUR END TIDAL CO2 MONITORING TRACE. WE GOT A DYNAMAP AND SPO2 SHOWED 97%. WE CHANGED THE ETCO2 MONITOR AND WE GOT A GOOD TRACE. THIS CAUSED US TO GO DOWN A DIFFERENT ROUTE OF MANAGEMENT, BECAUSE WE THOUGHT WE WERE NOT ABLE TO OXYGENATE THE PATIENT. WE REMOVED THE ENDOTRACHEAL TUBE, REINSERTED IT, AND IN THAT TIME PATIENT'S SPO2 DROPPED SIGNIFICANTLY. THIS WAS THE MONITOR THAT WAS IN THE PEDIATRIC BAY'. THE SEQUENCE OF EVENTS PROVIDED DID NOT CLARIFY THE REASONS FOR REINTUBATION OR THE 'DIFFERENT ROUTE OF MANAGEMENT'.

  Patient problems: Insufficient Information

  MAUDE report 23077179 ↗
• MalfunctionSep 11, 2025Defective Alarm; Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MICROSTREAM EXTENSION INDICATING THAT ALARMS FOR TECHNICAL ERROR MEASUREMENT IS ABSENT. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028407 ↗
• MalfunctionAug 13, 2025No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE DEVICE FAILED THE NOISE CHECK PROCEDURE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794063 ↗
• InjuryJun 17, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT ON (B)(6) 2025, AT 6 PM, THE ETCO2 MODULE STOPPED WORKING DURING USE, AND IT WAS INDICATED THE INTERRUPTION IN MONITORING RESULTED IN SEVERE HARM. ANOTHER MODULE WAS USED TO CONTINUE CAPNOGRAPHY ALONG WITH A SPOT CHECK MONITOR FOR SPO2. THERE WAS NO OBVIOUS DAMAGE TO THE DEVICE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22233700 ↗
• MalfunctionMar 17, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE CUSTOMER REQUESTED A SPEAKER ASSEMBLY. IT IS UNKNOWN IF THERE WAS AN ISSUE WITH SPEAKER. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624474 ↗
• InjuryAug 13, 2024Defective Alarm; Defective Alarm

  THE CUSTOMER REPORTED THAT THEY WERE EXPECTING TO GET A RED ALARM, BUT WHEN PATIENT SPO2 FELL BELOW 88, WHICH WAS THE SET LIMIT, THERE WAS NO YELLOW/RED ALARM REPORTED. THE PATIENT WAS MOVED TO ANOTHER ROOM DUE TO THIS ROOM FAILING TO ALARM WHEN IT SHOULD HAVE. THE DEVICE WAS IN CLINICAL USE. THE PATIENT WAS NEAR CODING WITH SEVERE DESATURATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19974386 ↗
• MalfunctionJun 14, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE MODULE INTERMITTENTLY STOPS WORKING BY FREEZING OR LOSING POWER. THE DEVICE WAS NOT IN CLINICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14688933 ↗
• MalfunctionApr 7, 2022No Audible Alarm; No Audible Alarm

  IT WAS REPORTED: MONITOR DIDN¿T ALARM.THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047475 ↗
• MalfunctionFeb 14, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT AN ALARM MALFUNCTION MESSAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13527293 ↗
• InjuryOct 18, 2021Intermittent Communication Failure; Intermittent Communication Failure

  THE CUSTOMER REPORTED THE ETCO2 IS NOT CONSISTENTLY REGISTERING ON THEIR INTELLIVUE MICROSTREAM EXTENSION. TO PROTECT THE PATIENT AIRWAY, INTUBATION WAS PERFORMED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 12648133 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA ORAL FEEDBACK THAT THE CO2 MICROSTREAM EXTENSION MECHANISM FOR CONNECTING TO THE X3 DEVICE IS NOT ENGAGING THE X3 AND CAUSING THE X3 MODULE TO DROP. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821445 ↗
• MalfunctionApr 13, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER CALLED PHILIPS TO REPORT THAT THEIR MICROSTREAM EXTENSION'S CONNECTOR PLUG WAS CHARRED. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655536 ↗
• MalfunctionNov 5, 2020No Display/Image

  THE CUSTOMER REPORTED THEIR INTELLIVUE MICROSTREAM EXTENSION WAS INVOLVED IN AN INCIDENT AND NOW THE DEVICE IS NOT SHOWING SPO2. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10791814 ↗
• MalfunctionDec 15, 2019Break; Device Fell

  THE CUSTOMER REPORTED TO PHILIPS THAT THEIR CO2 MICROSTREAM EXTENSION MODULE HAD A BROKEN LATCH AND WAS DROPPED BECAUSE OF THE DAMAGED LATCH. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9470928 ↗
• MalfunctionDec 15, 2019Break; Device Fell

  THE CUSTOMER REPORTED TO PHILIPS THAT THEIR CO2 MICROSTREAM EXTENSION MODULE HAD A BROKEN LATCH AND WAS DROPPED BECAUSE OF THE DAMAGED LATCH. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9470924 ↗
• InjurySep 18, 2019Device Fell

  THE CUSTOMER REPORTED THAT AN X3 MODULE FELL FROM THE CO2 MICROSTREAM EXTENSION MODULE. THE X3 STRUCK THE TOP OF THE PREGNANT NURSE'S BELLY. THE NURSE REQUIRED SEVERAL HOURS OF MONITORING IN THE HOSPITAL'S LABOR AND DELIVERY UNIT. NO ADDITIONAL INFORMATION CONCERNING THE INJURY TO THE NURSE OR HER FETUS IS AVAILABLE. NO DELAY IN PATIENT TREATMENT HAS BEEN REPORTED.

  Patient problems: Injury

  MAUDE report 9082527 ↗
• MalfunctionMay 7, 2019Defective Device; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE LOCKING CLIP OF THE INTELLIVUE MICROSTREAM EXTENSION IS NOT WORKING PROPERLY AND IS STUCK (DEFECTIVE LOCKING CLIP). NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8585913 ↗