Monitor, physiological, patient (without arrhythmia detection or alarms): medical device reports filed with FDA

2,065 reports carry this product code, 2001–2026; 5 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.

2,065
reports with this product code: 0% of all MAUDE reports; 546
reports, 12 months to August 2026: 125 in the 12 months before; 91.1%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

Product code MWI is FDA's classification for "Monitor, physiological, patient (without arrhythmia detection or alarms)" (cardiovascular panel), a class 2 device. 2,065 medical device reports carry this product code, 0% of the MAUDE database, from June 2001 to August 2026.

546 reports arrived in the 12 months to August 2026, up 337% from 125 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 (91.1%), injury (5.6%) and death (2.2%). 5 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
Rad-97	314	246	0.3%	99.1%
Xper Flex Cardio Physiomonitoring System	211	6	2.4%	89.1%
Carescape	3	2,289	0.1%	99.4%
Radical-7	2	79	1.7%	97.3%
IntelliVue Multi-Measurement Module X3	1	401	1.7%	93.5%

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 - 15750 Alton Pkwy	579	28%
Masimo - 40 Parker	212	10.3%
Welch Allyn	208	10.1%
Remote Diagnostic Technologies	51	2.5%
Philips Medizin Systeme B Blingen	40	1.9%
Masimo	23	1.1%
Welch Allyn Protocol	11	0.5%
Bayer Healthcare	5	0.2%
Philips Healthcare	5	0.2%
Ge Healthcare	4	0.2%
Mindray Ds USA	4	0.2%
Philips North America	4	0.2%
Philips Medical Systems Nederland	3	0.1%
Draeger Medical Systems	2	0.1%
Bayer	1	0%

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

Death2.2%45

Injury5.6%115

Malfunction91.1%1,882

Other0.7%15

Not given0.4%8

Who filed

Manufacturer report92%1,899

Voluntary report3.8%78

User facility report0%0

Distributor report0%0

Not given4.3%88

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect measurementthe device measured wrongly	249	12.1%
Unexpected shutdown	242	11.7%
Device alarm system	109	5.3%
No audible alarm	99	4.8%
Sensing intermittently	98	4.7%
High readingsreadings were too high	90	4.4%
Display or visual feedback problem	79	3.8%
Incorrect, inadequate or imprecise result or readings	69	3.3%
Inappropriate or unexpected reset	60	2.9%
Device operates differently than expectedthe device behaved unexpectedly	53	2.6%
Failure to power up	49	2.4%
Device displays incorrect message	48	2.3%
Low readingsreadings were too low	47	2.3%
Application program freezes or fails to launch	45	2.2%
Insufficient device problem information	43	2.1%
Breakthe device broke	41	2%
Communication or transmission problemthe device could not communicate or transmit	38	1.8%
Unable to obtain readings	38	1.8%
Defective alarm	37	1.8%
Sparking	35	1.7%

Questions about monitor, physiological, patient (without arrhythmia detection or alarms) reports

What is product code MWI?

FDA's classification code for "Monitor, physiological, patient (without arrhythmia detection or alarms)", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,065 reports through August 2026, 546 of them in the latest 12 months.

Which brands appear most often?

Rad-97 (314), Xper Flex Cardio Physiomonitoring System (211), Carescape (3), Radical-7 (2) and IntelliVue Multi-Measurement Module X3 (1). 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.