Microstream CO2 Extension 865377Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Microstream CO2 Extension (Model B) works together with the IntelliVue Multi-Measurement Module (MMS) and the IntelliVue X2 Multi-Measurement Module and IntelliVue MP2 Patient Monitor. The base product provides CO2 waveform, inspired minimum (imCO2), endtidal CO2 (etCO2) and Airway Respiration Rate (awRR) of intubated and non-intubated adult, pediatric and neonatal patients varies care areas inside the hospital. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838021563), received between Jun 11, 2019 and Aug 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Device Alarm System1
- Imprecise or Erratic Results1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50395619 ↗MalfunctionMay 4, 2020Device Alarm System; Therapeutic or Diagnostic Output Failure
THE CUSTOMER REPORTED THAT ON (B)(6) 2020 THE WAVE FORM FOR THE INTELLIVUE MICROSTREAM CO2 EXTENSION INTERMITTENTLY DISAPPEARS, NO ALARM WAS TRIGGERED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10020432 ↗MalfunctionJun 11, 2019Break; Detachment of Device or Device Component
THE CUSTOMER REPORTED "RECURRING MICROSTREAM CO2 EXTENSION TAB BREAKAGES", WHICH CAUSED AN INTELLIVUE MULTI MEASUREMENT SERVER X2 TO FALL OFF THE MONITOR AND ONTO THE FLOOR. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8686375 ↗
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- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
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- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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