System, measurement, blood-pressure, non-invasive: medical device reports filed with FDA

3,560 reports carry this product code, 1992–2026; 9 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.

3,560
reports with this product code: 0% of all MAUDE reports; 1,157
reports, 12 months to August 2026: 336 in the 12 months before; 88.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code DXN is FDA's classification for "System, measurement, blood-pressure, non-invasive" (cardiovascular panel), a class 2 device. 3,560 medical device reports carry this product code, 0% of the MAUDE database, from August 1992 to August 2026.

1,157 reports arrived in the 12 months to August 2026, up 244% from 336 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 (88.7%), injury (8.4%) and other (1.3%). 9 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
Safedraw	268	85	0%	97.7%
Vs4 Vital Signs Monitor	164	0	0.6%	99.4%
Ihealth	6	13	0%	98.3%
Panorama Central Station With Telepack	5	0	0%	99.7%
Datascope	2	0	7.3%	40.2%
Power cord 110V	2	93	0%	98.4%
Atlas	1	31	0%	96.1%
Braun	1	24	0.5%	71.8%
Invacare	1	0	17%	27%

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
Medline Industries	906	25.4%
Mhc Medical Products	462	13%
Philips Medical Systems	337	9.5%
Edwards Lifesciences	68	1.9%
Mindray Ds USA	66	1.9%
Philips North America	34	1%
Welch Allyn	23	0.6%
Nihon Kohden	10	0.3%
Datascope	8	0.2%
Spacelabs Healthcare	8	0.2%
Alaris Medical Systems	5	0.1%
Welch Allyn Protocol	5	0.1%
Philips Goldway Shenzhen Industrial	4	0.1%
Ge Medical Systems	3	0.1%
Icu Medical	2	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

Death0.4%16

Injury8.4%300

Malfunction88.7%3,158

Other1.3%46

Not given1.1%40

Who filed

Manufacturer report89.3%3,180

Voluntary report5.9%210

User facility report0%0

Distributor report2%70

Not given2.8%100

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect, inadequate or imprecise result or readings	699	19.6%
Device operational issue	391	11%
Fluid/blood leak	343	9.6%
Device operates differently than expectedthe device behaved unexpectedly	283	7.9%
Device displays incorrect message	280	7.9%
Output problem	260	7.3%
High readingsreadings were too high	248	7%
Incorrect measurementthe device measured wrongly	191	5.4%
Incorrect or inadequate test results	177	5%
Inflation problem	154	4.3%
High test results	140	3.9%
Unable to obtain readings	138	3.9%
Failure to power up	116	3.3%
Low readingsreadings were too low	98	2.8%
Image display error/artifact	87	2.4%
Device provides uninformative message	63	1.8%
Insufficient device problem information	56	1.6%
No audible alarm	51	1.4%
No audible prompt/feedback	44	1.2%
Display or visual feedback problem	42	1.2%

Questions about system, measurement, blood-pressure, non-invasive reports

What is product code DXN?

FDA's classification code for "System, measurement, blood-pressure, non-invasive", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,560 reports through August 2026, 1,157 of them in the latest 12 months.

Which brands appear most often?

Safedraw (268), Vs4 Vital Signs Monitor (164), Ihealth (6), Panorama Central Station With Telepack (5) and Datascope (2). 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.