Computer, diagnostic, programmable: medical device reports filed with FDA

4,492 reports carry this product code, 1997–2026; 11 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,492
reports with this product code: 0% of all MAUDE reports; 526
reports, 12 months to August 2026: 571 in the 12 months before; 84.6%
classified as malfunction: 62.3% across all reports; 1.2%
classified as death, as reported: 0.9% across all reports

Product code DQK is FDA's classification for "Computer, diagnostic, programmable" (cardiovascular panel), a class 2 device. 4,492 medical device reports carry this product code, 0% of the MAUDE database, from January 1997 to August 2026.

526 reports arrived in the 12 months to August 2026, close to the 571 of 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 (84.6%), injury (13.7%) and death (1.2%). 11 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Carto 3 System	994	23	0.8%	91.7%
Merge Hemodynamics	325	0	0%	98.8%
Merge Hemo	187	0	1.1%	98.9%
iLab Ultrasound Imaging System	102	85	0.2%	98.5%
Affera	40	992	2.1%	32.4%
Advisor HD Grid Mapping Catheter, Sensor Enabled	4	32	3.3%	53.8%
Acist	1	14	10.6%	14.9%
Ampere RF Ablation Generator	1	14	1.1%	55.9%
Carescape	1	2,289	0.1%	99.4%
Dorado Pta Dilatation Catheter	1	0	0%	92.6%
Zio Monitor	1	221	0%	2.5%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
St Jude Medical	666	14.8%
Biosense Webster	650	14.5%
Merge Healthcare	518	11.5%
Edwards Lifesciences	307	6.8%
Siemens Healthcare	42	0.9%
Biosense Webster Irwindale	36	0.8%
Irhythm Technologies	31	0.7%
Philips Medical Systems	25	0.6%
Ge Healthcare	12	0.3%
Spacelabs Healthcare	7	0.2%
Biosense Webster Juarez	4	0.1%
Medtronic Heart Valves Division	4	0.1%
Philips North America	3	0.1%
Agilent Technologies	2	0%
Boston Scientific - Fremont Ce	2	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

Death1.2%53

Injury13.7%615

Malfunction84.6%3,798

Other0.4%17

Not given0.2%9

Who filed

Manufacturer report94.1%4,226

Voluntary report1.6%73

User facility report0%0

Distributor report0%1

Not given4.3%192

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Communication or transmission problemthe device could not communicate or transmit	622	13.8%
Display or visual feedback problem	447	10%
Incorrect measurementthe device measured wrongly	270	6%
Signal artifact/noise	223	5%
Device displays incorrect message	208	4.6%
Failure to transmit record	195	4.3%
Incorrect, inadequate or imprecise result or readings	186	4.1%
No display/image	154	3.4%
Device operates differently than expectedthe device behaved unexpectedly	149	3.3%
Application interface becomes non-functional or program exits abnormally	135	3%
Application program problem	129	2.9%
Output problem	114	2.5%
Computer software problema software problem	113	2.5%
Pacing problem	101	2.2%
Device issuea problem with the device	96	2.1%
Failure of device to self-test	94	2.1%
Data problem	91	2%
Device operational issue	88	2%
Failure to power up	85	1.9%
Image orientation incorrect	83	1.8%

Questions about computer, diagnostic, programmable reports

What is product code DQK?

FDA's classification code for "Computer, diagnostic, programmable", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,492 reports through August 2026, 526 of them in the latest 12 months.

Which brands appear most often?

Carto 3 System (994), Merge Hemodynamics (325), Merge Hemo (187), iLab Ultrasound Imaging System (102) and Affera (40). 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.