EMMA™ 605100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07350046131743), received between Feb 4, 2021 and Jan 20, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2022Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE WAS ZEROED AND PROVIDED LOW READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311629 ↗
• MalfunctionOct 21, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE WAS MEASURING TOO HIGH DURING A ROUTINE CHECK. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677557 ↗
• MalfunctionJul 27, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE IS PROVIDING LOWER THAN EXPECTED READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235785 ↗
• MalfunctionJun 3, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE DOES NOT READ VALUES CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930453 ↗
• MalfunctionApr 30, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE IS PROVIDING LOWER THAN EXPECTED READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753427 ↗
• MalfunctionApr 29, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE KPA VALUE FALLS OUTSIDE THE LIMIT VALUE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744677 ↗
• MalfunctionMar 11, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE READINGS WERE INACCURATE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462224 ↗
• MalfunctionFeb 4, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE SHOWS TOO HIGH A VALUE, AT 5% CO2 IT SHOWS 5.9%. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11282494 ↗