EMMARecalls & reported problems across all models

We found 2 models of EMMA by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2020 and Sep 9, 2022 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EMMA problems

EMMA models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EMMA™ mmHg

  Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
  18 reports
• EMMA™ 605100

  Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
  8 reports

Recent EMMA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE MEASUREMENTS WERE TOO HIGH, EVEN AFTER PERFORMING THE ZEROING PROCEDURE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396689 ↗
• MalfunctionAug 25, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE DEVICE WILL SWITCH OFF AUTOMATICALLY AFTER 2 TO 3 MINUTES AFTER POWER ON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299017 ↗
• MalfunctionMay 19, 2022No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED NO SOUND FROM THE SPEAKER. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14440176 ↗
• 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 ↗
• MalfunctionDec 30, 2021Incorrect Measurement; Incorrect Measurement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122380 ↗
• MalfunctionDec 30, 2021Incorrect Measurement; Incorrect Measurement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122370 ↗
• MalfunctionDec 23, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE MEASUREMENT VALUES ARE TOO LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082146 ↗
• MalfunctionNov 24, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE READS A CO VALUE BETWEEN 15% AND 20% DIFFERENT COMPARED WITH A BLOOD SAMPLE MEASUREMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872318 ↗
• MalfunctionNov 24, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE READS A CO VALUE BETWEEN 15% AND 20% DIFFERENT COMPARED WITH A BLOOD SAMPLE MEASUREMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872292 ↗
• MalfunctionNov 10, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE WAS OUT OF TOLERANCE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790496 ↗
• MalfunctionNov 10, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE WAS OUT OF TOLERANCE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790455 ↗
• 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 ↗
• MalfunctionOct 15, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE GAVE INACCURATE READINGS, LOW CO2. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643495 ↗
• MalfunctionOct 1, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THE DEVICE DETECTOR LENS IS RECESSED AND SHUT DOWN AUTOMATICALLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565623 ↗
• MalfunctionSep 30, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DETECTOR LENS IS RECESSED. SOMETIME IS ABLE TO USE BUT NOT SURE IF THE VALUE IS ACCURATE UNDER THIS ERROR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558487 ↗

Other Masimo Corporation products

• RAD-G4 models · 194 reports · 4 recalls
• Rad-973 models · 330 reports
• Rad-8 Horizontal Signal Extraction Pulse Oximeter2 models · 123 reports
• Radius VSM7 models · 13 reports · 2 recalls
• RD SET12 models · 49 reports · 1 recall
• Rad-5 Handheld signal extraction pulse oximeter2 models · 76 reports
• LNCS-II rainbow2 models · 1 reports · 1 recall
• Rad-5v Handheld signal extraction pulse oximeter2 models · 46 reports