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FDA product code DWJ · class 2 · Cardiovascular
System, thermal regulating: medical device reports filed with FDA
26,725 reports carry this product code, 1992–2026; 28 brands with a page.
- 26,725
- reports with this product code
- 0.1% of all MAUDE reports
- 1,874
- reports, 12 months to August 2026
- 2,848 in the 12 months before
- 90.9%
- classified as malfunction
- 62.3% across all reports
- 0.2%
- classified as death, as reported
- 0.9% across all reports
Product code DWJ is FDA's classification for "System, thermal regulating" (cardiovascular panel), a class 2 device. 26,725 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to August 2026.
1,874 reports arrived in the 12 months to August 2026, down 34% from 2,848 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 (90.9%), injury (8.2%) and other (0.4%). 28 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 |
|---|---|---|
| Medivance 1725056 | 21,259 | 79.5% |
| Dymax -2523003 | 1,045 | 3.9% |
| 3m | 456 | 1.7% |
| Productos Para El Cuidado De La Salud -9611590 | 400 | 1.5% |
| Stryker Medical-Kalamazoo | 392 | 1.5% |
| Smiths Medical Asd | 86 | 0.3% |
| 3m Health Care | 51 | 0.2% |
| Mmj De Cv Usd | 50 | 0.2% |
| Perfusion Systems | 43 | 0.2% |
| Smith S Medical Asd | 36 | 0.1% |
| Covidien/Formerly Tyco Healthcare | 28 | 0.1% |
| Kimberly-Clark | 16 | 0.1% |
| Stryker Medical | 15 | 0.1% |
| Covidien Formerly Tyco Healthcare | 14 | 0.1% |
| St Paul | 10 | 0% |
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 |
|---|---|---|
| Insufficient cooling | 3,509 | 13.1% |
| Defective component | 3,492 | 13.1% |
| Device sensing problem | 2,902 | 10.9% |
| Failure to pump | 2,664 | 10% |
| Inaccurate flow rate | 2,464 | 9.2% |
| Temperature problem | 1,841 | 6.9% |
| Insufficient heating | 1,833 | 6.9% |
| Gas/air leak | 1,612 | 6% |
| Device displays incorrect message | 1,489 | 5.6% |
| Restricted flow rate | 1,489 | 5.6% |
| Decreased pump speed | 1,061 | 4% |
| Circuit failure | 926 | 3.5% |
| Pumping problem | 739 | 2.8% |
| Nonstandard device | 605 | 2.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 578 | 2.2% |
| Failure to calibrate | 560 | 2.1% |
| Computer operating system problem | 537 | 2% |
| Overheating of device | 519 | 1.9% |
| Fluid/blood leak | 445 | 1.7% |
| Operating system becomes nonfunctional | 355 | 1.3% |
Questions about system, thermal regulating reports
What is product code DWJ?
FDA's classification code for "System, thermal regulating", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.
How many reports carry this code?
26,725 reports through August 2026, 1,874 of them in the latest 12 months.
Which brands appear most often?
Arctic Sun 5000 (15,431), Arctic Sun Stat (1,537), Arctic Sun Temperature Management System, ArcticGel Pads (1,135), Arcticsun 5000 (908) and Arctic Sun Temperature Management System Temperature Cable (601). 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.