Medical device data system: medical device reports filed with FDA

2,983 reports carry this product code, 2011–2026; 7 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.

2,983
reports with this product code: 0% of all MAUDE reports; 217
reports, 12 months to August 2026: 291 in the 12 months before; 95.5%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code OUG is FDA's classification for "Medical device data system" (general Hospital panel), a class 1 device. 2,983 medical device reports carry this product code, 0% of the MAUDE database, from May 2011 to August 2026.

217 reports arrived in the 12 months to August 2026, down 25% from 291 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 (95.5%), injury (1.6%) and other (0.6%). 7 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
Unknown Fota Sftwr	784	194	0%	100%
Sftwr Mmt-6121 Fota Android Ous/Us	648	0	0%	99.5%
Sftwr Mmt-6122 Fota Ios Ous/Us	632	0	0%	99.8%
Pentax	396	2,443	0.1%	98.4%
Pkg Connected Or Hub Base System	35	61	0.6%	98.1%
Epic	15	32	1.2%	59.7%
Carelink System	10	0	0.3%	98.3%

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 Minimed	2,087	70%
Stryker Endoscopy-San Jose	55	1.8%
Biomerieux	19	0.6%
Merge Healthcare	7	0.2%
Agfa Healthcare	6	0.2%
Tandem Diabetes Care	3	0.1%
Asahi Intecc	2	0.1%
Medtronic Milaca	2	0.1%
Draeger Medical Systems	1	0%
Philips / Respironics	1	0%
Spacelabs Healthcare	1	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

Death0.3%10

Injury1.6%49

Malfunction95.5%2,850

Other0.6%18

Not given1.9%56

Who filed

Manufacturer report95%2,835

Voluntary report4.4%130

User facility report0%0

Distributor report0.1%2

Not given0.5%16

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

Device problems coded

Device problem (FDA code)	Reports	Share
Computer software problema software problem	1,500	50.3%
Wireless communication problema wireless connection problem	1,255	42.1%
No display/image	86	2.9%
Data problem	58	1.9%
Problem with software installation	51	1.7%
Communication or transmission problemthe device could not communicate or transmit	36	1.2%
Output problem	36	1.2%
Patient data problem	31	1%
Application program problem	24	0.8%
Device operates differently than expectedthe device behaved unexpectedly	19	0.6%
Connection problema connection problem	17	0.6%
Image display error/artifact	16	0.5%
Application program problem: medication error	14	0.5%
Device alarm system	12	0.4%
Improper or incorrect procedure or method	11	0.4%
Poor quality image	11	0.4%
Device markings/labelling problema problem with the device markings or label	8	0.3%
Application program problem: dose calculation error	6	0.2%
Computer operating system problem	6	0.2%
Date/time-related software problem	6	0.2%

Questions about medical device data system reports

What is product code OUG?

FDA's classification code for "Medical device data system", class 1, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,983 reports through August 2026, 217 of them in the latest 12 months.

Which brands appear most often?

Unknown Fota Sftwr (784), Sftwr Mmt-6121 Fota Android Ous/Us (648), Sftwr Mmt-6122 Fota Ios Ous/Us (632), Pentax (396) and Pkg Connected Or Hub Base System (35). 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.