Devices › Monitor, physiological, patient (without arrhythmia detection or alarms)
Device brand name · Cardiovascular monitor
Xper Flex Cardio Physiomonitoring System: medical device reports filed with FDA
211 reports name it, 2015–2026. Manufacturer given most often on reports: Invivo. Product code MWI.
- 211
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 6
- reports, 12 months to August 2026
- 3 in the 12 months before
- 89.1%
- classified as malfunction
- 91.1% across the product code
- 2.4%
- classified as death, as reported
- 5 reports · not verified by FDA
211 medical device reports received by FDA name the brand "Xper Flex Cardio Physiomonitoring System" (cardiovascular monitor); the manufacturer given most often on reports is Invivo; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
6 reports arrived in the 12 months to August 2026, up 100% from 3 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 (89.1%), injury (8.5%) and death (2.4%); across all monitor, physiological, patient (without arrhythmia detection or alarms) reports (product code MWI) death is recorded in 2.2% and malfunction in 91.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (10%), output problem (8.1%) and application program freezes or fails to launch (7.6%). The patient problems coded most often are no patient involvement, cardiac arrest and arrhythmia. 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 2,065 reports carrying product code MWI. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 21 | 10% | 3.3% |
| Output problem | 17 | 8.1% | 1.5% |
| Application program freezes or fails to launch | 16 | 7.6% | 2.2% |
| Incorrect measurementthe device measured wrongly | 11 | 5.2% | 12.1% |
| Display or visual feedback problem | 9 | 4.3% | 3.8% |
| Device alarm system | 8 | 3.8% | 5.3% |
| Therapeutic or diagnostic output failure | 8 | 3.8% | 0.9% |
| Unable to obtain readings | 8 | 3.8% | 1.8% |
| Defibrillation/stimulation problem | 6 | 2.8% | 0.5% |
| Device displays incorrect message | 6 | 2.8% | 2.3% |
| Measurement system incompatibility | 6 | 2.8% | 0.3% |
| No display/image | 6 | 2.8% | 1.3% |
| Defective component | 5 | 2.4% | 0.3% |
| Defective devicethe device was defective | 5 | 2.4% | 0.4% |
| Application program problem | 3 | 1.4% | 0.4% |
| Computer operating system problem | 3 | 1.4% | 0.6% |
| Computer software problema software problem | 2 | 0.9% | 1.1% |
| Device sensing problem | 2 | 0.9% | 0.8% |
| Inflation problem | 2 | 0.9% | 0.1% |
| Insufficient device problem information | 2 | 0.9% | 2.1% |
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 |
|---|---|---|
| No patient involvement | 5 | 2.4% |
| Cardiac arrestthe heart stopped | 4 | 1.9% |
| Arrhythmia | 1 | 0.5% |
| Asystole | 1 | 0.5% |
| Complaint, ill-defined | 1 | 0.5% |
| Deaththe patient died; cause not stated by this term | 1 | 0.5% |
| Injurya physical injury | 1 | 0.5% |
| Low oxygen saturation | 1 | 0.5% |
| Non specific ekg/ECG changes | 1 | 0.5% |
| Shockshock, a collapse of the circulation | 1 | 0.5% |
| Skin discoloration | 1 | 0.5% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Xper Flex Cardio Physiomonitoring System | Product code MWI | All MAUDE reports |
|---|---|---|---|
| Reports | 211 | 2,065 | 26,136,888 |
| Share of that pool | — | 10.2% | 0% |
| Classified as death, per 1,000 reports | 24 | 22 | 9 |
| Classified as injury | 8.5% | 5.6% | 36.2% |
| Classified as malfunction | 89.1% | 91.1% | 62.3% |
| Filed by the manufacturer | 99.1% | 92% | 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 MWI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Rad-97 | 316 | 246 | 0.3% |
| Carescape | 4,902 | 2,289 | 0.1% |
| Radical-7 | 516 | 79 | 1.7% |
| IntelliVue Multi-Measurement Module X3 | 478 | 401 | 1.7% |
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 Xper Flex Cardio Physiomonitoring System reports
How many FDA reports name Xper Flex Cardio Physiomonitoring System?
211 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
malfunction (89.1%), injury (8.5%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (10%), output problem (8.1%), application program freezes or fails to launch (7.6%), incorrect measurement (5.2%) and display or visual feedback problem (4.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Xper Flex Cardio Physiomonitoring System 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.