Device manufacturer, as written on reports

Philips Medical Systems: medical device reports filed with FDA

109,510 reports name it as the manufacturer of the device involved, 1994–2026.

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.

109,510
reports naming it as manufacturer: 0.4% of all MAUDE reports; 1,113
reports, 12 months to August 2026: 1,044 in the 12 months before; 95.7%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

109,510 medical device reports received by FDA give Philips Medical Systems as the manufacturer of the device involved, 0.4% of the MAUDE database, from January 1994 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,113 reports arrived in the 12 months to August 2026, close to the 1,044 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 (95.7%), death (2.2%) and injury (1.6%). 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
Heartstart Mrx	Automated external defibrillators (non-wearable)	17,653	0	0.7%
HeartStart MRx -EMS Defibrillator	Automated external defibrillators (non-wearable)	13,540	33	0.8%
Heart Start XL	Automated external defibrillators (non-wearable)	13,339	95	0.9%
Heartstart Onsite	Automated external defibrillators (non-wearable)	10,519	0	0.8%
HeartStart XL+ Defibrillator/Monitor	Automated external defibrillators (non-wearable)	10,367	210	0.4%
Heartstart Frx	Automated external defibrillators (non-wearable)	5,764	2	1.3%
MX40 1.4 GHz Smart Hopping	Detector and alarm, arrhythmia	4,096	6	1.3%
Heartstart Mrx - Ems Defibrillator	Automated external defibrillators (non-wearable)	2,206	0	2.3%
Heartstream Fr2	Automated external defibrillators (non-wearable)	2,058	0	6.6%
Heartstart Xl	Automated external defibrillators (non-wearable)	1,495	1	0.9%
Heartstart Mrx-Ems Defibrillator	Automated external defibrillators (non-wearable)	1,478	0	3.6%
Fr3 Refurb Ecg Aed - Japanese	Automated external defibrillators (non-wearable)	1,260	0	0.2%
Battery 14 8v 6 3 Ah Li-Ion Battery	Automated external defibrillators (non-wearable)	1,178	0	0.2%
IntelliVue Multi Measurement Server X2	Monitor, physiological, patient(with arrhythmia detection or alarms)	1,146	135	1.7%
Patient Information Center iX	Monitor, physiological, patient(with arrhythmia detection or alarms)	1,099	619	10.4%
Heartstream Xl	Automated external defibrillators (non-wearable)	1,095	0	1.9%
Heartstart Sla Battery	Oximeter	969	0	0.1%
Intellivue Information Center Ix	Monitor, physiological, patient(with arrhythmia detection or alarms)	937	0	7.5%
Ac Power Module	Automated external defibrillators (non-wearable)	691	0	0.1%
Mx40 2 4 Ghz Smart Hopping	Detector and alarm, arrhythmia	670	0	1.5%
HeartStart FR3	Automated external defibrillators (non-wearable)	669	3	3.4%
Heartstart Home	Over-the-counter automated external defibrillator	659	0	1.3%
Mp70 Intellivue Patient Monitor	Detector and alarm, arrhythmia	627	0	15.4%
Piic Ix Hardware	Monitor, physiological, patient(with arrhythmia detection or alarms)	538	0	4.6%
IntelliVue MX40 1.4GHz	Monitor, physiological, patient(with arrhythmia detection or alarms)	348	297	2%
Heartstart Xl + Defibrillator/Monitor	Automated external defibrillators (non-wearable)	302	0	1.9%
Mp50 Intellivue Patient Monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	261	0	7%
Intellivue Info Center Ix	Monitor, physiological, patient(with arrhythmia detection or alarms)	237	0	9%
Intellivue Mx40 802 11a/B/G	Detector and alarm, arrhythmia	227	0	3%
Heartstart Mrx Airworthy	Automated external defibrillators (non-wearable)	223	0	0%

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)	88,450	80.8%
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	9,221	8.4%
DSI	Detector and alarm, arrhythmia	6,079	5.6%
DQA	Oximeter	990	0.9%
LDD	Dc-defibrillator, low-energy, (including paddles)	843	0.8%
NSA	Over-the-counter automated external defibrillator	655	0.6%
IZI	System, x-ray, angiographic	406	0.4%
DXN	System, measurement, blood-pressure, non-invasive	337	0.3%
HGM	System, monitoring, perinatal	326	0.3%
LNH	System, nuclear magnetic resonance imaging	245	0.2%

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

Death2.2%2,462

Injury1.6%1,710

Malfunction95.7%104,834

Other0.3%381

Not given0.1%123

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

Questions about Philips Medical Systems reports

How many FDA device reports name Philips Medical Systems as manufacturer?

109,510 reports through August 2026, 1,113 of them in the latest 12 months.

Which of its brands appear most often?

Heartstart Mrx (17,653), HeartStart MRx -EMS Defibrillator (13,540), Heart Start XL (13,339), Heartstart Onsite (10,519) and HeartStart XL+ Defibrillator/Monitor (10,367).

Which device types does it report on?

automated external defibrillators (non-wearable) (80.8%), monitor, physiological, patient(with arrhythmia detection or alarms) (8.4%), detector and alarm, arrhythmia (5.6%) and oximeter (0.9%).

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.