Devices › Device types
FDA product code DSI · class 2 · Cardiovascular
Detector and alarm, arrhythmia: medical device reports filed with FDA
33,398 reports carry this product code, 1992–2026; 30 brands with a page.
- 33,398
- reports with this product code
- 0.1% of all MAUDE reports
- 399
- reports, 12 months to August 2026
- 959 in the 12 months before
- 90.5%
- classified as malfunction
- 62.3% across all reports
- 1.5%
- classified as death, as reported
- 0.9% across all reports
Product code DSI is FDA's classification for "Detector and alarm, arrhythmia" (cardiovascular panel), a class 2 device. 33,398 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1992 to August 2026.
399 reports arrived in the 12 months to August 2026, down 58% from 959 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 (90.5%), injury (7.8%) and death (1.5%). 30 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
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 |
|---|---|---|
| Medtronic Europe Sarl | 12,377 | 37.1% |
| Philips Medical Systems | 6,079 | 18.2% |
| Ipg Mfg Switzerland | 5,027 | 15.1% |
| Medtronic Singapore Operations | 1,930 | 5.8% |
| Philips North America | 1,273 | 3.8% |
| Philips Medizin Systeme B Blingen | 1,170 | 3.5% |
| Medtronic Med Rel | 1,023 | 3.1% |
| Medtronic Med Rel Medtronic Puerto Rico | 849 | 2.5% |
| Welch Allyn Protocol | 711 | 2.1% |
| Spacelabs Healthcare | 405 | 1.2% |
| Medtronic | 313 | 0.9% |
| Ge Healthcare | 256 | 0.8% |
| Mindray Ds USA | 129 | 0.4% |
| Irhythm Technologies | 98 | 0.3% |
| Medtronic Milaca | 68 | 0.2% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Under-sensing | 7,922 | 23.7% |
| Over-sensing | 5,216 | 15.6% |
| No audible alarm | 3,714 | 11.1% |
| Premature discharge of battery | 3,392 | 10.2% |
| Signal artifact/noise | 1,877 | 5.6% |
| Device sensing problem | 1,600 | 4.8% |
| No audible prompt/feedback | 1,499 | 4.5% |
| Migration or expulsion of device | 1,292 | 3.9% |
| Communication or transmission problemthe device could not communicate or transmit | 1,109 | 3.3% |
| Device alarm system | 973 | 2.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 972 | 2.9% |
| Unable to obtain readings | 751 | 2.2% |
| Reset problem | 701 | 2.1% |
| Failure to interrogate | 696 | 2.1% |
| Invalid sensing | 672 | 2% |
| Device displays incorrect message | 491 | 1.5% |
| Electromagnetic interference | 440 | 1.3% |
| No device output | 437 | 1.3% |
| Battery problema problem with the battery | 399 | 1.2% |
| No display/image | 396 | 1.2% |
Questions about detector and alarm, arrhythmia reports
What is product code DSI?
FDA's classification code for "Detector and alarm, arrhythmia", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.
How many reports carry this code?
33,398 reports through August 2026, 399 of them in the latest 12 months.
Which brands appear most often?
Reveal LINQ (19,183), MX40 1.4 GHz Smart Hopping (5,120), Reveal Xt (2,037), Mx40 2 4 Ghz Smart Hopping (783) and Reveal Dx (730). 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.