EMMA™ Kit 3639Recalls & reported problems
Masimo Corporation · EMMA™ Kit · Class 2
Quick summary
This Masimo EMMA Kit is a carbon-dioxide gas analyzer. The 25 reports mostly describe the device shutting off by itself and giving readings that were too high, too low or erratic, with no deaths and no injuries mentioned. No recalls name this device. Reports rose to 11 from 3 in the earlier period.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07350046131033), received between Nov 30, 2022 and Jun 14, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (8 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.
Reports received per month
Most reported problems
Device problems
- Unexpected Shutdown8
- High Readings7
- Low Readings6
- Incorrect Measurement2
- Defective Alarm1
- Device Alarm System1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE DEVICE HAS "ERRATIC READINGS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25496864 ↗MalfunctionMar 16, 2026High Readings
THE CUSTOMER REPORTED THE EMMAS WERE PROVIDING "INACCURATE READINGS" AS THE EMMAS WERE "GETTING HIGHER READINGS IN COMPARISON TO THEIR OTHER END TIDAL CO2 DEVICE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24612629 ↗MalfunctionMar 14, 2026High Readings
THE CUSTOMER REPORTED THE EMMAS WERE PROVIDING "INACCURATE READINGS" AS THE EMMAS WERE "GETTING HIGHER READINGS IN COMPARISON TO THEIR OTHER END TIDAL CO2 DEVICE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601455 ↗MalfunctionFeb 18, 2026Low Readings
THE CUSTOMER REPORTED THE EMMA WAS "CONSISTENTLY GETTING A LOW READING" AS THE MEASUREMENTS WERE "USUALLY 5-8 UNDER EVEN AFTER PERFORMING ZEROING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384718 ↗MalfunctionFeb 17, 2026Low Readings
THE CUSTOMER REPORTED THE EMMA WAS "CONSISTENTLY GETTING A LOW READING" AS THE MEASUREMENTS WERE "USUALLY 5-8 UNDER EVEN AFTER PERFORMING ZEROING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373918 ↗MalfunctionDec 30, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS POWERING OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931633 ↗MalfunctionDec 30, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE POWER[ED] OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931627 ↗MalfunctionDec 27, 2025Device Alarm System; Unexpected Shutdown; Device Alarm System; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "WOULD KEEP TURNING ITSELF OFF AFTER A FEW MINUTES." PER ADDITIONAL INFORMATION FROM THE CUSTOMER, NO ALARMS WERE PROVIDED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901426 ↗MalfunctionNov 11, 2025High Readings; High Readings
THE CUSTOMER REPORTED THAT THE ETCO2 READINGS WERE HIGHER THAN EXPECTED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528808 ↗MalfunctionNov 5, 2025Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THE DEVICE ETCO2 READINGS WERE LOWER THAN EXPECTED, NO ALARMS OR ERROR MESSAGES WERE PRESENT ON THE DEVICE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482763 ↗MalfunctionSep 16, 2025Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED OBTAINING "HIGH ETCO2 LEVELS" WITH THE EMMA AS THE ETCO2 READINGS WERE "CONSISTENTLY HIGHER THAN 65," HOWEVER A BLOOD GAS DRAW PROVIDED A CO2 VALUE OF 52. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069770 ↗MalfunctionAug 26, 2025Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings
THE CUSTOMER REPORTED THAT THE DEVICE READING[S] ARE INACCURATE; THE VALUES WERE SIGNIFICANTLY LOWER AS WELL AS INCONSISTENT. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901132 ↗MalfunctionMay 22, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE "POWER TURNS OFF WHILE USING IT (EVEN AFTER CHANGING THE BATTERY), POOR AIRWAY ADAPTER RECOGNITION." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073971 ↗MalfunctionJul 23, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "TURNS OFF EVEN WHEN REPLACED WITH FULL CHARGE BATTERIES." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19812494 ↗MalfunctionJun 7, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "SHUTS OFF" DURING MONITORING. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487072 ↗MalfunctionMay 24, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "SWITCHES OFF WHILE RESUSCITATION IS IN PROGRESS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397582 ↗MalfunctionMay 21, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "SHUTDOWN BY ITSELF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367298 ↗MalfunctionMar 5, 2024High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE WAS "OUT OF TOLERANCE; READING 10 MMHG HIGHER THAN IT SHOULD". THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18842093 ↗MalfunctionAug 16, 2023High Readings; High Readings
THE CUSTOMER REPORTED THE "EMMA DOESN'T MEASURE CORRECTLY" AS THE READINGS WERE TOO HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17558828 ↗MalfunctionMay 23, 2023Defective Alarm; Defective Alarm
THE CUSTOMER REPORTED THE EMMA WAS "NOT ALARMING WHEN READINGS ARE PAST ALARM LIMITS." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989747 ↗MalfunctionFeb 27, 2023High Readings; High Readings
THE CUSTOMER REPORTED THE "ETCO2 VALUE IS MUCH HIGHER THAN EXPECTED." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16445577 ↗MalfunctionFeb 10, 2023Low Readings; Low Readings
THE CUSTOMER REPORTED THE EMMA MODULE HAS A LOW ETCO2 READING. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16358002 ↗MalfunctionJan 6, 2023Low Readings; Low Readings
THE CUSTOMER REPORTED THE DEVICE WAS READING LOWER THAN THE OTHER UNITS IN COMPARISON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16118476 ↗MalfunctionNov 30, 2022High Readings; High Readings
THE CUSTOMER REPORTED THE ETCO2 VALUE WAS UNSTABLE, THE VALUE SEEMS TO BE ABNORMALLY HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15889982 ↗
Other Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase devices
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- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall607 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE485 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE471 reports
- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.