Oximeter: medical device reports filed with FDA

14,003 reports carry this product code, 1991–2026; 26 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,003
reports with this product code: 0.1% of all MAUDE reports; 902
reports, 12 months to August 2026: 399 in the 12 months before; 91.6%
classified as malfunction: 62.3% across all reports; 2.6%
classified as death, as reported: 0.9% across all reports

Product code DQA is FDA's classification for "Oximeter" (cardiovascular panel), a class 2 device. 14,003 medical device reports carry this product code, 0.1% of the MAUDE database, from December 1991 to August 2026.

902 reports arrived in the 12 months to August 2026, up 126% from 399 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (91.6%), injury (4.2%) and death (2.6%). 26 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Nellcor	1,748	215	3.9%	89.3%
Heartstart Sla Battery	948	0	0.1%	99.6%
Rad-8 Horizontal	625	0	2.4%	96.8%
Radical-7 Handheld	534	0	1.3%	98.3%
Radical-7	514	79	1.7%	97.3%
N595 Pulse Oximeter	513	0	0%	99.2%
Oximax N-595 Pulse Oximeter	409	0	0.5%	98.6%
Rad-8	399	0	3.5%	96%
Rad-57	221	9	0%	94.1%
Nellcor Oximax N-65	199	0	0%	99.5%
EarlyVue VS30	191	181	0%	99.5%
Oximax N-560 Pulse Oximeter	174	0	4.7%	92.5%
Nellcor N595 Pulse Oximeter	157	0	0%	98.1%
Sensor	7	50	0.3%	59.7%
Respironics	4	2,239	0.3%	98.7%
Codemaster Xl	3	0	2.1%	96%
Datascope	2	0	7.3%	40.2%
FloTrac Sensor	2	10	0%	96.9%
Rad-97	2	246	0.3%	99.1%
Alaris	1	79	1.1%	85.8%
Atlas	1	31	0%	96.1%
IntelliVue Multi-Measurement Module X3	1	401	1.7%	93.5%
Mallinckrodt	1	1	1.2%	57.3%
Medline	1	26,184	0.1%	97.9%
Mx40 2 4 Ghz Smart Hopping	1	0	1.5%	97.6%
R Series Defibrillator	1	0	0.9%	98.6%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Masimo	3,272	23.4%
Masimo - 40 Parker	2,211	15.8%
Philips Medical Systems	990	7.1%
Nellcor Puritan Bennett	870	6.2%
Masimo - 15750 Alton Pkwy	861	6.1%
Covidien Formerly Tyco Healthcare	357	2.5%
Philips Medizin Systeme B Blingen	308	2.2%
Carefusion Sd	267	1.9%
Covidien	237	1.7%
St Paul	93	0.7%
Covidien/Formerly Tyco Healthcare	61	0.4%
Mmj De Cv Usd	37	0.3%
Welch Allyn Protocol	22	0.2%
Ge Healthcare	20	0.1%
Datascope	13	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2.6%360

Injury4.2%585

Malfunction91.6%12,826

Other1.2%166

Not given0.5%66

Who filed

Manufacturer report94.9%13,287

Voluntary report2.1%295

User facility report0%0

Distributor report0%7

Not given3%414

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect measurementthe device measured wrongly	2,323	16.6%
No audible alarm	1,392	9.9%
Display or visual feedback problem	1,107	7.9%
Device operates differently than expectedthe device behaved unexpectedly	823	5.9%
Low readingsreadings were too low	745	5.3%
Device alarm system	730	5.2%
High readingsreadings were too high	456	3.3%
Device stops intermittentlythe device stopped now and then	411	2.9%
Failure to run on ac/dc	404	2.9%
Sensing intermittently	401	2.9%
No display/image	395	2.8%
Battery problema problem with the battery	391	2.8%
Component missing	327	2.3%
Unexpected shutdown	302	2.2%
Inappropriate or unexpected reset	284	2%
Image display error/artifact	256	1.8%
Incorrect, inadequate or imprecise result or readings	229	1.6%
Unable to obtain readings	223	1.6%
Breakthe device broke	199	1.4%
Device sensing problem	167	1.2%

Questions about oximeter reports

What is product code DQA?

FDA's classification code for "Oximeter", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

14,003 reports through August 2026, 902 of them in the latest 12 months.

Which brands appear most often?

Nellcor (1,748), Heartstart Sla Battery (948), Rad-8 Horizontal (625), Radical-7 Handheld (534) and Radical-7 (514). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.