Devices › Detector and alarm, arrhythmia
Device brand name · Patient monitor
Intellivue Mx40 802 11a/B/G: medical device reports filed with FDA
329 reports name it, 2014–2025. Manufacturer given most often on reports: Philips Medical Systems. Product code DSI.
- 329
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 0
- reports, 12 months to August 2026
- 25 in the 12 months before
- 94.5%
- classified as malfunction
- 90.5% across the product code
- 3%
- classified as death, as reported
- 10 reports · not verified by FDA
329 medical device reports received by FDA name the brand "Intellivue Mx40 802 11a/B/G" (patient monitor); the manufacturer given most often on reports is Philips Medical Systems; received from January 2014 to May 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 25 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 (94.5%), death (3%) and injury (2.4%); across all detector and alarm, arrhythmia reports (product code DSI) death is recorded in 1.5% and malfunction in 90.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no audible alarm (39.8%), no audible prompt/feedback (19.5%) and device displays incorrect message (8.5%). The patient problems coded most often are no patient involvement, cardiac arrest and death. 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 33,398 reports carrying product code DSI. 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 |
|---|---|---|---|
| No audible alarm | 131 | 39.8% | 11.1% |
| No audible prompt/feedback | 64 | 19.5% | 4.5% |
| Device displays incorrect message | 28 | 8.5% | 1.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 23 | 7% | 2.9% |
| Device alarm system | 12 | 3.6% | 2.9% |
| No device output | 12 | 3.6% | 1.3% |
| Inaudible or unclear audible prompt/feedback | 10 | 3% | 0.7% |
| Defective alarm | 7 | 2.1% | 0.7% |
| Defective component | 5 | 1.5% | 0.2% |
| Device inoperablethe device could not be used | 5 | 1.5% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 1.2% | 3.3% |
| Defective devicethe device was defective | 4 | 1.2% | 0.4% |
| Display or visual feedback problem | 4 | 1.2% | 0.3% |
| Alarm not visible | 3 | 0.9% | 0.1% |
| Component missing | 3 | 0.9% | 0.2% |
| Insufficient device problem information | 3 | 0.9% | 0.5% |
| Loose or intermittent connection | 2 | 0.6% | 0% |
| Low audible alarm | 2 | 0.6% | 0.1% |
| Noise, audible | 2 | 0.6% | 0.1% |
| Output problem | 2 | 0.6% | 0.4% |
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 | 64 | 19.5% |
| Cardiac arrestthe heart stopped | 3 | 0.9% |
| Deaththe patient died; cause not stated by this term | 2 | 0.6% |
| Burn, thermal | 1 | 0.3% |
| Loss of consciousnesspassing out | 1 | 0.3% |
| Low oxygen saturation | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Intellivue Mx40 802 11a/B/G | Product code DSI | All MAUDE reports |
|---|---|---|---|
| Reports | 329 | 33,398 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 30 | 15 | 9 |
| Classified as injury | 2.4% | 7.8% | 36.2% |
| Classified as malfunction | 94.5% | 90.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 DSI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Reveal LINQ | 19,184 | 264 | 0% |
| MX40 1.4 GHz Smart Hopping | 5,135 | 6 | 1.3% |
| Reveal Xt | 2,037 | 0 | 0.1% |
| Mx40 2 4 Ghz Smart Hopping | 785 | 0 | 1.5% |
| Reveal Dx | 730 | 0 | 0.4% |
| Acuity Central Monitoring | 710 | 0 | 0% |
| Mp70 Intellivue Patient Monitor | 682 | 0 | 15.4% |
| IntelliVue Multi Measurement Server X2 | 1,924 | 135 | 1.7% |
| Spacelabs Ultraview Sl Command Module | 200 | 4 | 8.5% |
| IntelliVue MX800 patient monitor | 502 | 54 | 10.6% |
| Patient Connector | 207 | 83 | 0% |
| IntelliVue MX40 2.4GHz | 192 | 56 | 6.8% |
| Passport 2 Monitor | 469 | 0 | 0.2% |
| IntelliVue MP5 | 261 | 73 | 10.7% |
| Zio AT | 711 | 90 | 3.5% |
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." 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 Intellivue Mx40 802 11a/B/G reports
How many FDA reports name Intellivue Mx40 802 11a/B/G?
329 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (94.5%), death (3%) and injury (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no audible alarm (39.8%), no audible prompt/feedback (19.5%), device displays incorrect message (8.5%), device operates differently than expected (7%) and device alarm system (3.6%). 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 Intellivue Mx40 802 11a/B/G 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.