Device manufacturer, as written on reports

Philips North America: medical device reports filed with FDA

21,282 reports name it as the manufacturer of the device involved, 2020–2026.

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.

21,282
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,507
reports, 12 months to August 2026: 2,010 in the 12 months before; 96.1%
classified as malfunction: 62.3% across all reports; 1.3%
classified as death, as reported: 0.9% across all reports

21,282 medical device reports received by FDA give Philips North America as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2020 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,507 reports arrived in the 12 months to August 2026, down 25% from 2,010 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 (96.1%), injury (2.6%) and death (1.3%). 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 monitor/defib	Automated external defibrillators (non-wearable)	3,640	107	0.5%
HeartStart XL+ Defibrillator/Monitor	Automated external defibrillators (non-wearable)	2,789	210	0.4%
HeartStart MRx -EMS Defibrillator	Automated external defibrillators (non-wearable)	2,274	33	0.8%
HeartStart	Automated external defibrillators (non-wearable)	1,364	837	1.4%
Heart Start XL	Automated external defibrillators (non-wearable)	1,177	95	0.9%
MX40 1.4 GHz Smart Hopping	Detector and alarm, arrhythmia	1,031	6	1.3%
Hs1+ W G Defib Japanese Exchg	Automated external defibrillators (non-wearable)	679	0	0.7%
Hs1 Onsite Defib Us English Exchange	Automated external defibrillators (non-wearable)	618	0	0.8%
Hs1 W B Onsite Defib Us English Exchg	Automated external defibrillators (non-wearable)	536	4	1.5%
PHILIPS HeartStart FRx	Automated external defibrillators (non-wearable)	465	301	1.3%
Fr3 Defib Ecg Japanese Exchange	Automated external defibrillators (non-wearable)	412	0	0%
Fr3 Defibrillator Ecg Ap T Exchange	Automated external defibrillators (non-wearable)	341	0	0%
Patient Information Center iX	Monitor, physiological, patient(with arrhythmia detection or alarms)	318	619	10.4%
Heartstart Frx Defibrillator	Automated external defibrillators (non-wearable)	317	0	0.6%
Frx+ W G Defib Japanese Exchg	Automated external defibrillators (non-wearable)	277	1	1.1%
Frx W B Defib Us English Exchg	Automated external defibrillators (non-wearable)	267	2	2.6%
Hs1 Defibrillator Japanese Exchange	Automated external defibrillators (non-wearable)	219	0	0%
DreamStation Auto CPAP	Ventilator, non-continuous (respirator)	214	27,741	0.9%
Pic Ix Hardware	Monitor, physiological, patient(with arrhythmia detection or alarms)	212	0	10.4%
Heartstart Onsite	Automated external defibrillators (non-wearable)	121	0	0.8%
Mx40 2 4 Ghz Smart Hopping	Detector and alarm, arrhythmia	106	0	1.5%
Intellivue Mx40 802 11a/B/G	Detector and alarm, arrhythmia	92	0	3%
DreamStation	Ventilator, non-continuous (respirator)	64	1,703	1.6%
Efficia Dfm100	Automated external defibrillators (non-wearable)	53	0	0.6%
Heartstart Mrx	Automated external defibrillators (non-wearable)	45	0	0.7%
Heartstart Frx	Automated external defibrillators (non-wearable)	27	2	1.3%
Heartstart Xl	Automated external defibrillators (non-wearable)	27	1	0.9%
DreamStation Auto BiPAP	Ventilator, non-continuous (respirator)	24	871	1.8%
REMstar Pro C-Flex+	Ventilator, non-continuous (respirator)	23	4,689	1.2%
DreamStation CPAP Pro	Ventilator, non-continuous (respirator)	21	674	0.8%

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)	17,434	81.9%
DSI	Detector and alarm, arrhythmia	1,273	6%
NSA	Over-the-counter automated external defibrillator	895	4.2%
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	874	4.1%
BZD	Ventilator, non-continuous (respirator)	523	2.5%
IYN	System, imaging, pulsed doppler, ultrasonic	42	0.2%
DXN	System, measurement, blood-pressure, non-invasive	34	0.2%
DPS	Electrocardiograph	20	0.1%
CBK	Ventilator, continuous, facility use	12	0.1%
DQA	Oximeter	9	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

Death1.3%276

Injury2.6%547

Malfunction96.1%20,456

Other0%2

Not given0%1

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

Questions about Philips North America reports

How many FDA device reports name Philips North America as manufacturer?

21,282 reports through August 2026, 1,507 of them in the latest 12 months.

Which of its brands appear most often?

HeartStart MRx monitor/defib (3,640), HeartStart XL+ Defibrillator/Monitor (2,789), HeartStart MRx -EMS Defibrillator (2,274), HeartStart (1,364) and Heart Start XL (1,177).

Which device types does it report on?

automated external defibrillators (non-wearable) (81.9%), detector and alarm, arrhythmia (6%), over-the-counter automated external defibrillator (4.2%) and monitor, physiological, patient(with arrhythmia detection or alarms) (4.1%).

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.