Device manufacturer, as written on reports

Philips Healthcare: medical device reports filed with FDA

4,689 reports name it as the manufacturer of the device involved, 2008–2022.

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.

4,689
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 82.5%
classified as malfunction: 62.3% across all reports; 5.6%
classified as death, as reported: 0.9% across all reports

4,689 medical device reports received by FDA give Philips Healthcare as the manufacturer of the device involved, 0% of the MAUDE database, from April 2008 to May 2022. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and 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 (82.5%), injury (10.9%) and death (5.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Heart Start XL	Automated external defibrillators (non-wearable)	848	95	0.9%
Heartstart Mrx	Automated external defibrillators (non-wearable)	621	0	0.7%
Heartstart Mrx - Ems Defibrillator	Automated external defibrillators (non-wearable)	313	0	2.3%
HeartStart MRx -EMS Defibrillator	Automated external defibrillators (non-wearable)	257	33	0.8%
Allura Xper FD20	Interventional fluoroscopic x-ray system	244	676	0.6%
Heartstream Xl	Automated external defibrillators (non-wearable)	229	0	1.9%
Ac Power Module	Automated external defibrillators (non-wearable)	187	0	0.1%
Heartstart Mrx-Ems Defibrillator	Automated external defibrillators (non-wearable)	184	0	3.6%
Allura Xper FD10	System, x-ray, angiographic	174	404	1.3%
Heartstart Xl	Automated external defibrillators (non-wearable)	74	1	0.9%
Achieva 1 5t Nova	System, nuclear magnetic resonance imaging	60	11	2.6%
Achieva 1.5T New	System, nuclear magnetic resonance imaging	49	31	0%
Philips Information Center	Monitor, physiological, patient(with arrhythmia detection or alarms)	44	0	70.7%
Battery 14 8v 6 3 Ah Li-Ion Battery	Automated external defibrillators (non-wearable)	37	0	0.2%
Allura Xper FD10/10	System, x-ray, angiographic	36	111	0.3%
External Paddles	Automated external defibrillators (non-wearable)	32	0	0%
Codemaster Xl	Dc-defibrillator, low-energy, (including paddles)	16	0	2.1%
Codemaster Xl+	Dc-defibrillator, low-energy, (including paddles)	11	0	2.8%
Philips	Monitor, physiological, patient(with arrhythmia detection or alarms)	11	0	6.3%
Heartstart Mrx Ems Defibrillator	Automated external defibrillators (non-wearable)	3	0	0.6%
Brilliance 64	System, x-ray, tomography, computed	1	0	0.6%
Everflo Oxygen Concentrator	Generator, oxygen, portable	1	0	13.5%
Heartstart Frx	Automated external defibrillators (non-wearable)	1	2	1.3%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
MKJ	Automated external defibrillators (non-wearable)	2,935	62.6%
IZI	System, x-ray, angiographic	578	12.3%
LNH	System, nuclear magnetic resonance imaging	357	7.6%
OWB	Interventional fluoroscopic x-ray system	258	5.5%
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	164	3.5%
IZL	System, x-ray, mobile	78	1.7%
JAA	System, x-ray, fluoroscopic, image-intensified	56	1.2%
LDD	Dc-defibrillator, low-energy, (including paddles)	40	0.9%
KPR	System, x-ray, stationary	22	0.5%
DXJ	Display, cathode-ray tube, medical	19	0.4%

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

Death5.6%264

Injury10.9%509

Malfunction82.5%3,869

Other0.8%36

Not given0.2%11

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Philips Healthcare reports

How many FDA device reports name Philips Healthcare as manufacturer?

4,689 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Heart Start XL (848), Heartstart Mrx (621), Heartstart Mrx - Ems Defibrillator (313), HeartStart MRx -EMS Defibrillator (257) and Allura Xper FD20 (244).

Which device types does it report on?

automated external defibrillators (non-wearable) (62.6%), system, x-ray, angiographic (12.3%), system, nuclear magnetic resonance imaging (7.6%) and interventional fluoroscopic x-ray system (5.5%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.