Device brand name · Ventricular assist bypass

Heartmate Power Module Eu: medical device reports filed with FDA

244 reports name it, 2020–2026. Manufacturer given most often on reports: Thoratec. Product code DSQ.

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.

244
device reports naming the brand: 0% of all MAUDE reports · about 39 a year; 30
reports, 12 months to August 2026: 51 in the 12 months before; 100%
classified as malfunction: 37% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

244 medical device reports received by FDA name the brand "Heartmate Power Module Eu" (ventricular assist bypass); the manufacturer given most often on reports is Thoratec; received from March 2020 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

30 reports arrived in the 12 months to August 2026, down 41% from 51 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 ventricular (assist) bypass reports (product code DSQ) death is recorded in 14.6% and malfunction in 37%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are mechanical problem (50%), insufficient device problem information (11.1%) and failure to charge (5.7%). The patient problems coded most often are no patient involvement. 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.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%244

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%244

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 158,083 reports carrying product code DSQ. 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
Mechanical problema mechanical problem	122	50%	5.5%
Insufficient device problem information	27	11.1%	1.8%
Failure to charge	14	5.7%	0.4%
Failure to power up	13	5.3%	0.2%
Electrical power problem	10	4.1%	2.1%
Noise, audible	8	3.3%	0.4%
Electrical /electronic property probleman electrical or electronic problem	7	2.9%	1.9%
Communication or transmission problemthe device could not communicate or transmit	5	2%	0.8%
Contamination /decontamination problem	5	2%	0.1%
Improper or incorrect procedure or method	5	2%	0.5%
Display or visual feedback problem	4	1.6%	0.7%
Failure to interrogate	3	1.2%	0.1%
Leak/splashthe device leaked	3	1.2%	0.2%
Material deformation	3	1.2%	0.9%
Nonstandard device	3	1.2%	0%
Complete loss of power	2	0.8%	1.7%
Corrodedthe device corroded	2	0.8%	0.2%
Product quality problem	2	0.8%	0%
Battery problema problem with the battery	1	0.4%	6.5%
Computer software problema software problem	1	0.4%	0%

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.

Patient problems coded

Patient problem (FDA code)	Reports	Share
No patient involvement	8	3.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Heartmate Power Module Eu	Product code DSQ	All MAUDE reports
Reports	244	158,083	26,136,888
Share of that pool	—	0.2%	0%
Classified as death, per 1,000 reports	0	146	9
Classified as injury	0%	48.3%	36.2%
Classified as malfunction	100%	37%	62.3%
Filed by the manufacturer	100%	97%	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 DSQ

Brand	Reports	Latest 12 months	Classified as death
HeartWare Ventricular Assist System - Pump	36,450	1,304	13.4%
Heartware Ventricular Assist System	14,550	0	6.9%
HeartMate 3 LVAS Implant Kit	13,500	626	38%
Thoratec HeartMate 3 LVAS Implant Kit	8,130	3,008	29.7%
HeartMate 3 Left Ventricular Assist System	5,858	122	18.6%
HeartWare Ventricular Assist System - Controller 2.0	5,831	132	0.5%
HeartWare Ventricular Assist System - Battery	5,010	47	0%
Thoratec HeartMate 3 System Controller	3,591	1,387	0%
HeartMate 3 System Controller	3,473	247	0.3%
HeartWare Ventricular Assist System - Driveline	3,003	159	1.5%
HeartWare Ventricular Assist System - Pump/Driveline	2,160	147	16.6%
Heartmate Mobile Power Unit Na	2,096	4	0.1%
Heartware Ventricular Assist System-Pump	1,424	0	19.9%
Heartware Ventricular Assist System- Pump	1,306	0	35.4%
Heartmate Mobile Power Unit N/A	1,234	519	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 Heartmate Power Module Eu reports

How many FDA reports name Heartmate Power Module Eu?

244 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 30 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?

mechanical problem (50%), insufficient device problem information (11.1%), failure to charge (5.7%), failure to power up (5.3%) and electrical power problem (4.1%). 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 Heartmate Power Module Eu 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.