Device manufacturer, as written on reports

Philips Medizin Systeme B Blingen: medical device reports filed with FDA

6,100 reports name it as the manufacturer of the device involved, 2021–2026.

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.

6,100
reports naming it as manufacturer: 0% of all MAUDE reports; 2,323
reports, 12 months to August 2026: 1,266 in the 12 months before; 89.5%
classified as malfunction: 62.3% across all reports; 3.9%
classified as death, as reported: 0.9% across all reports

6,100 medical device reports received by FDA give Philips Medizin Systeme B Blingen as the manufacturer of the device involved, 0% of the MAUDE database, from February 2021 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,323 reports arrived in the 12 months to August 2026, up 83% from 1,266 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 (89.5%), injury (6.6%) and death (3.9%). 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
IntelliVue Multi Measurement Server X2	Monitor, physiological, patient(with arrhythmia detection or alarms)	731	135	1.7%
Intellivue X3	Monitor, physiological, patient(with arrhythmia detection or alarms)	695	0	1.5%
Patient Information Center iX	Monitor, physiological, patient(with arrhythmia detection or alarms)	509	619	10.4%
IntelliVue Multi-Measurement Module X3	Monitor, physiological, patient(with arrhythmia detection or alarms)	477	401	1.7%
IntelliVue MX450 Patient Monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	342	123	7.6%
IntelliVue MX550 Patient Monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	255	82	5.4%
IntelliVue MX800 patient monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	248	54	10.6%
EarlyVue VS30	Oximeter	189	181	0%
IntelliVue MP5	Monitor, physiological, patient(with arrhythmia detection or alarms)	165	73	10.7%
Intellivue Mx750 Patient Monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	156	3	6.3%
Avalon Fm30 Fetal Monitor	System, monitoring, perinatal	145	3	21%
Avalon FM20 Fetal Monitor	System, monitoring, perinatal	123	6	7.6%
IntelliVue MX500 Patient Monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	113	35	4%
Intellivue Mx700 Patient Monitor	Monitor, physiological, patient(with arrhythmia detection or alarms)	54	3	12.8%
Intellivue Mp2	Monitor, physiological, patient(with arrhythmia detection or alarms)	50	9	1.2%
Pic Ix Hardware	Monitor, physiological, patient(with arrhythmia detection or alarms)	8	0	10.4%

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
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	3,792	62.2%
DSI	Detector and alarm, arrhythmia	1,170	19.2%
HGM	System, monitoring, perinatal	543	8.9%
DQA	Oximeter	308	5%
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)	40	0.7%
DPS	Electrocardiograph	33	0.5%
DXJ	Display, cathode-ray tube, medical	30	0.5%
CCK	Analyzer, gas, carbon-dioxide, gaseous-phase	29	0.5%
OLW	Index-generating electroencephalograph software	22	0.4%
DSA	Cable, transducer and electrode, patient, (including connector)	6	0.1%

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

Death3.9%236

Injury6.6%405

Malfunction89.5%5,458

Other0%0

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 Medizin Systeme B Blingen reports

How many FDA device reports name Philips Medizin Systeme B Blingen as manufacturer?

6,100 reports through August 2026, 2,323 of them in the latest 12 months.

Which of its brands appear most often?

IntelliVue Multi Measurement Server X2 (731), Intellivue X3 (695), Patient Information Center iX (509), IntelliVue Multi-Measurement Module X3 (477) and IntelliVue MX450 Patient Monitor (342).

Which device types does it report on?

monitor, physiological, patient(with arrhythmia detection or alarms) (62.2%), detector and alarm, arrhythmia (19.2%), system, monitoring, perinatal (8.9%) and oximeter (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.