Devices › System, measurement, blood-pressure, non-invasive
Device brand name · System measurement blood-pressure non-invasive
Safedraw: medical device reports filed with FDA
305 reports name it, 2016–2026. Manufacturer given most often on reports: Merit Medical Singapore Pte. Product code DXN.
- 305
- device reports naming the brand
- 0% of all MAUDE reports · about 29 a year
- 85
- reports, 12 months to August 2026
- 57 in the 12 months before
- 97.7%
- classified as malfunction
- 88.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
305 medical device reports received by FDA name the brand "Safedraw" (system measurement blood-pressure non-invasive); the manufacturer given most often on reports is Merit Medical Singapore Pte; received from January 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
85 reports arrived in the 12 months to August 2026, up 49% from 57 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 (97.7%) and injury (2%); across all system, measurement, blood-pressure, non-invasive reports (product code DXN) death is recorded in 0.4% and malfunction in 88.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (88.2%), pressure problem (3.9%) and leak/splash (2.3%). The patient problems coded most often are hemorrhage/blood loss/bleeding, low blood pressure/ hypotension and blood loss. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,560 reports carrying product code DXN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Fluid/blood leak | 269 | 88.2% | 9.6% |
| Pressure problem | 12 | 3.9% | 0.4% |
| Leak/splashthe device leaked | 7 | 2.3% | 0.7% |
| Loose or intermittent connection | 6 | 2% | 0.4% |
| Crackthe device cracked | 4 | 1.3% | 0.1% |
| Incorrect measurementthe device measured wrongly | 3 | 1% | 5.4% |
| Device handling problem | 2 | 0.7% | 0% |
| Improper flow or infusion | 2 | 0.7% | 0% |
| Incorrect, inadequate or imprecise result or readings | 2 | 0.7% | 19.6% |
| Increase in pressure | 2 | 0.7% | 0.3% |
| Material deformation | 2 | 0.7% | 0.1% |
| Material integrity problema problem with the device material | 2 | 0.7% | 0.3% |
| Material twisted/bent | 2 | 0.7% | 0.1% |
| No pressure | 2 | 0.7% | 0% |
| Air/gas in device | 1 | 0.3% | 0% |
| Backflow | 1 | 0.3% | 0.1% |
| Breakthe device broke | 1 | 0.3% | 0.9% |
| Connection problema connection problem | 1 | 0.3% | 0.1% |
| Contamination | 1 | 0.3% | 0% |
| Contamination /decontamination problem | 1 | 0.3% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 6 | 2% |
| Low blood pressure/ hypotension | 5 | 1.6% |
| Blood loss | 2 | 0.7% |
| Exposure to body fluids | 1 | 0.3% |
| Eye injury | 1 | 0.3% |
| High blood pressure/ hypertension | 1 | 0.3% |
| Thrombosis/thrombus | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Safedraw | Product code DXN | All MAUDE reports |
|---|---|---|---|
| Reports | 305 | 3,560 | 26,136,888 |
| Share of that pool | — | 8.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 2% | 8.4% | 36.2% |
| Classified as malfunction | 97.7% | 88.7% | 62.3% |
| Filed by the manufacturer | 100% | 89.3% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code DXN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Vs4 Vital Signs Monitor | 164 | 0 | 0.6% |
| Ihealth | 362 | 13 | 0% |
| Panorama Central Station With Telepack | 357 | 0 | 0% |
| Datascope | 356 | 0 | 7.3% |
| Power cord 110V | 244 | 93 | 0% |
| Atlas | 305 | 31 | 0% |
| Braun | 365 | 24 | 0.5% |
| Invacare | 200 | 0 | 17% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Safedraw reports
How many FDA reports name Safedraw?
305 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 85 in the latest 12 months.
What kinds of events are reported?
malfunction (97.7%) and injury (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (88.2%), pressure problem (3.9%), leak/splash (2.3%), loose or intermittent connection (2%) and crack (1.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Safedraw was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.