Pronto™ Pulse CO-Oximeter® 9167Recalls & reported problems
Masimo Corporation · Class 2
Quick summary
This is a Masimo Pronto Pulse CO-Oximeter 9167, a handheld oximeter that measures pulse and blood oxygen, including hemoglobin levels. The 27 reports mostly describe readings that don't match reality — values running 2 to 3 points high compared with a blood draw — along with a few faded or missing display segments and times when no reading could be obtained. No deaths and no injuries were reported, and no recalls name this device.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00843997008921), received between Aug 28, 2017 and Sep 6, 2023 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (12 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
Device problems
- Incorrect Measurement12
- High Readings7
- Display or Visual Feedback Problem5
- Unable to Obtain Readings3
- Incorrect, Inadequate or Imprecise Result or Readings2
- Device Sensing Problem1
- Low Readings1
Patient problems
- No Consequences Or Impact To Patient18
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2023High Readings; High Readings
THE CUSTOMER REPORTED THE PRONTO, CABLE, AND SENSOR WERE "NOT PROVIDING ACCURATE READINGS" AS THE MEASUREMENTS WERE HIGHER "BY 2-3 DATA POINTS" COMPARED TO A BLOOD DRAW. THERE WAS NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695734 ↗MalfunctionSep 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE PRONTO, CABLE, AND SENSOR WERE "NOT PROVIDING ACCURATE READINGS" AS THE MEASUREMENTS WERE "OFF BY 2-3 DATA POINTS" COMPARED TO A BLOOD DRAW. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695722 ↗MalfunctionJan 14, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE HEMOGLOBIN READINGS ARE OFF BY A LOT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13260599 ↗MalfunctionSep 15, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478284 ↗MalfunctionMay 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED INCORRECT READINGS ON SPHB. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11842866 ↗MalfunctionMar 31, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY HAD FADED OR MISSING SEGMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11598746 ↗MalfunctionMar 31, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY HAD FADED OR MISSING SEGMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11598731 ↗MalfunctionAug 7, 2020High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE GIVES SPHB READINGS 2.2% TO 3.8% HIGHER COMPARED TO ANOTHER DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10379548 ↗MalfunctionJan 30, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED: "THE READINGS GIVEN ARE BETWEEN 1 TO 3 SPHB OUTSIDE OR WHAT THE LAB WORK IS SHOWING." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9650277 ↗MalfunctionMay 28, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY IS MISSING A DIGIT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8645948 ↗MalfunctionMar 28, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED LED SEGMENTS ON THE DISPLAY DO NOT ILLUMINATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8462851 ↗MalfunctionMar 6, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE PRONTO DEVICE HAS A DEAD LED SEGMENT ON THE TOP DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8396552 ↗MalfunctionJan 25, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THEY ARE HAVING CONCERNS ABOUT THE SLOW READINGS, HIGH READINGS AND NO READINGS AT ALL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8277845 ↗MalfunctionDec 31, 2018Incorrect Measurement; Unable to Obtain Readings; Device Sensing Problem; Incorrect Measurement; Unable to Obtain Readings; Device Sensing Problem
HE CUSTOMER REPORTED THE DEVICE PROVIDED SLOW READINGS, HIGH READINGS, AND NO READINGS AT ALL. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8207235 ↗MalfunctionDec 28, 2018Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE READINGS WITH THE DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8203732 ↗MalfunctionNov 27, 2018Low Readings; Low Readings
THE CUSTOMER REPORTED THE DEVICE IS PROVIDING LOW SPHB READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8109356 ↗MalfunctionSep 12, 2018Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE SPHB READINGS ARE INCORRECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7871427 ↗MalfunctionJun 29, 2018Unable to Obtain Readings; High Readings; Unable to Obtain Readings; High Readings
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED SLOW READINGS, HIGH READINGS, AND NO READINGS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7651933 ↗MalfunctionJun 28, 2018Unable to Obtain Readings; High Readings; Unable to Obtain Readings; High Readings
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED SLOW READINGS, HIGH READINGS, AND NO READINGS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7649189 ↗MalfunctionJun 7, 2018High Readings; High Readings
THE CUSTOMER REPORTED LOW READINGS, HIGH READINGS AND NO READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7581052 ↗MalfunctionJun 7, 2018High Readings; High Readings
THE CUSTOMER REPORTED LOW READINGS, HIGH READINGS AND NO READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7581050 ↗MalfunctionJun 7, 2018High Readings; High Readings
THE CUSTOMER REPORTED LOW READINGS, HIGH READINGS AND NO READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7581048 ↗MalfunctionDec 24, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE NURSING HOME WAS MONITORING THE HB STATUS OF AN ANEMIC PATIENT, WHO HAS NEEDED BLOOD TRANSFUSIONS IN THE PAST, USING THE PRONTO MONITOR. PRONTO WAS READING THE PATIENT AT 13-14 G/DL. QUESTIONING THE PRONTO READINGS, THE DON THEN PERFORMED AN (B)(6) TEST AND THE RESULTS SHOWED PATIENT WAS AT 5-6 G/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7145286 ↗MalfunctionSep 11, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE READINGS ARE ALWAYS INACCURATE (CUSTOMER DOES NOT KNOW WHICH PARAMETER IS INACCURATE). NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6855218 ↗MalfunctionSep 8, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED: "READING 17-18 FOR HEMOGLOBIN ON HEALTHY INDIVIDUALS. THIS IS INTERMITTENT AND NOT HAPPENING EVERY TIME IT IS IN USE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6851012 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.