Devices › Monitor, physiological, patient(with arrhythmia detection or alarms)
Device brand name · Physiologic monitoring system single-patient
Infinity Acute Care System (M540): medical device reports filed with FDA
244 reports name it, 2015–2026. Manufacturer given most often on reports: Draeger Medical Systems. Product code MHX.
- 244
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 19
- reports, 12 months to August 2026
- 48 in the 12 months before
- 78.3%
- classified as malfunction
- 82.1% across the product code
- 9%
- classified as death, as reported
- 22 reports · not verified by FDA
FDA's MAUDE database holds 244 reports that name the brand "Infinity Acute Care System (M540)" (physiologic monitoring system single-patient), received between March 2015 and August 2026; the manufacturer given most often on reports is Draeger Medical Systems. Spellings of one product vary from report to report.
19 reports arrived in the 12 months to August 2026, down 60% from 48 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 (78.3%), injury (12.7%) and death (9%); across all monitor, physiological, patient(with arrhythmia detection or alarms) reports (product code MHX) death is recorded in 5.9% and malfunction in 82.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device alarm system (11.9%), no audible prompt/feedback (10.7%) and incorrect, inadequate or imprecise result or readings (7.8%). The patient problems coded most often are low oxygen saturation, death and hypoxia. 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 32,636 reports carrying product code MHX. 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 |
|---|---|---|---|
| Device alarm system | 29 | 11.9% | 8.1% |
| No audible prompt/feedback | 26 | 10.7% | 3.5% |
| Incorrect, inadequate or imprecise result or readings | 19 | 7.8% | 1.2% |
| Intermittent communication failure | 19 | 7.8% | 0.5% |
| Disconnection | 17 | 7% | 0.3% |
| Unexpected shutdown | 17 | 7% | 1.4% |
| No display/image | 16 | 6.6% | 4.1% |
| Connection problema connection problem | 15 | 6.1% | 0.3% |
| No device output | 12 | 4.9% | 1% |
| No audible alarm | 10 | 4.1% | 11.5% |
| Unable to obtain readings | 10 | 4.1% | 2.3% |
| Device sensing problem | 8 | 3.3% | 0.3% |
| Low readingsreadings were too low | 8 | 3.3% | 0.4% |
| Defective alarm | 7 | 2.9% | 3.4% |
| Communication or transmission problemthe device could not communicate or transmit | 6 | 2.5% | 6% |
| Output problem | 6 | 2.5% | 3.2% |
| Display or visual feedback problem | 5 | 2% | 3.2% |
| Failure to sense | 5 | 2% | 0.2% |
| Insufficient device problem information | 5 | 2% | 1.3% |
| No visual prompts/feedback | 5 | 2% | 0.1% |
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 |
|---|---|---|
| Low oxygen saturation | 13 | 5.3% |
| Deaththe patient died; cause not stated by this term | 12 | 4.9% |
| Hypoxialow oxygen | 6 | 2.5% |
| Cardiac arrestthe heart stopped | 5 | 2% |
| Low blood pressure/ hypotension | 5 | 2% |
| Asystole | 3 | 1.2% |
| Bradycardiaslow heart rate | 3 | 1.2% |
| Cyanosis | 3 | 1.2% |
| Loss of consciousnesspassing out | 3 | 1.2% |
| Tachycardiafast heart rate | 3 | 1.2% |
| Apnea | 2 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.8% |
| Arrhythmia | 2 | 0.8% |
| Cardiopulmonary arrest | 2 | 0.8% |
| High blood pressure/ hypertension | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Infinity Acute Care System (M540) | Product code MHX | All MAUDE reports |
|---|---|---|---|
| Reports | 244 | 32,636 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 90 | 59 | 9 |
| Classified as injury | 12.7% | 11.2% | 36.2% |
| Classified as malfunction | 78.3% | 82.1% | 62.3% |
| Filed by the manufacturer | 100% | 93.4% | 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 MHX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Patient Information Center iX | 1,941 | 619 | 10.4% |
| uCor Heart Failure and Arrhythmia Management System | 1,877 | 762 | 0% |
| Tempus Pro | 1,850 | 108 | 0.5% |
| Cns-6201a | 1,720 | 0 | 0.8% |
| IntelliVue Multi Measurement Server X2 | 1,924 | 135 | 1.7% |
| Cns-6801a | 1,058 | 0 | 1.5% |
| Intellivue Information Center Ix | 952 | 0 | 7.5% |
| Intellivue X3 | 777 | 0 | 1.5% |
| Tempus Pro, Printer | 562 | 400 | 0% |
| Piic Ix Hardware | 538 | 0 | 4.6% |
| Xhibit Central Station | 492 | 154 | 0.8% |
| IntelliVue Multi-Measurement Module X3 | 478 | 401 | 1.7% |
| IntelliVue MX450 Patient Monitor | 448 | 123 | 7.6% |
| Pu-681ra | 437 | 222 | 1.4% |
| Cns-9700a | 393 | 0 | 0.3% |
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 Infinity Acute Care System (M540) reports
How many FDA reports name Infinity Acute Care System (M540)?
244 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 19 in the latest 12 months.
What kinds of events are reported?
malfunction (78.3%), injury (12.7%) and death (9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device alarm system (11.9%), no audible prompt/feedback (10.7%), incorrect, inadequate or imprecise result or readings (7.8%), intermittent communication failure (7.8%) and disconnection (7%). 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 Infinity Acute Care System (M540) 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.