IntelliSpace Cardiovascular: medical device reports filed with FDA

393 reports name it, 2025–2026. Manufacturer given most often on reports: Philips Medical Systems Nederland. Product code LLZ.

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.

393
device reports naming the brand: 0% of all MAUDE reports · about 393 a year; 393
reports, 12 months to August 2026: 0 in the 12 months before; 100%
classified as malfunction: 98.6% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

393 medical device reports received by FDA name the brand "IntelliSpace Cardiovascular" (cardiovascular image and information management system); the manufacturer given most often on reports is Philips Medical Systems Nederland; received from September 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

393 reports arrived in the 12 months to August 2026, with none 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 (100%); across all system, image processing, radiological reports (product code LLZ) death is recorded in 0.2% and malfunction in 98.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to transmit record (27.7%), application program problem (23.4%) and no display/image (13.2%). 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.

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%393

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%393

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 19,695 reports carrying product code LLZ. 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
Failure to transmit record	109	27.7%	0.7%
Application program problem	92	23.4%	0.7%
No display/image	52	13.2%	0.8%
Computer system security problem	45	11.5%	0.2%
Incorrect, inadequate or imprecise result or readings	45	11.5%	0.5%
Computer software problema software problem	34	8.7%	74.7%
Application program freezes or fails to launch	16	4.1%	0.1%
Data problem	4	1%	1.2%
Incorrect measurementthe device measured wrongly	4	1%	0.8%
Patient data problem	3	0.8%	3.7%
Unauthorized access to computer system	3	0.8%	0%
Communication or transmission problemthe device could not communicate or transmit	2	0.5%	2.6%
Display or visual feedback problem	2	0.5%	1%
Loss of data	2	0.5%	1.4%
Missing test results	2	0.5%	0%
No device output	2	0.5%	0.1%
Poor quality image	2	0.5%	0.2%
Unintended application program shut down	2	0.5%	0%
Installation-related problem	1	0.3%	2.1%

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.

In context

Measure	IntelliSpace Cardiovascular	Product code LLZ	All MAUDE reports
Reports	393	19,695	26,136,888
Share of that pool	—	2%	0%
Classified as death, per 1,000 reports	0	2	9
Classified as injury	0%	0.6%	36.2%
Classified as malfunction	100%	98.6%	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 LLZ

Brand	Reports	Latest 12 months	Classified as death
Impax Cv Outbound Results Management 2 08	13,239	0	0%
Impax Cv Outboung Results Management 2 08	1,582	0	0%
Impax Cv Reporting	989	0	0%
Impax Cv Outbound Results Mgmt 2 08	417	0	0%
Entrak 2500	247	0	0%
Itrak 3500	235	0	0%
Merge Unity Pacs	166	0	0.6%
Site~Rite 8 Ultrasound System	312	112	0%
Visera Elite Video System Center	2,688	572	0%
Guardian	557	350	0.4%
VISERA Pro VIDEO SYSTEM CENTER	637	96	0%
Emprint	463	39	2.6%
Spectrum Infusion Pump	147,363	15	0%
Tango Optimo	158	0	0%
Pk Dissecting Forceps Instrument	1,564	0	0%

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 IntelliSpace Cardiovascular reports

How many FDA reports name IntelliSpace Cardiovascular?

393 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 393 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to transmit record (27.7%), application program problem (23.4%), no display/image (13.2%), computer system security problem (11.5%) and incorrect, inadequate or imprecise result or readings (11.5%). 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 IntelliSpace Cardiovascular 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.