Reported Reactions

Devices › Monitor, physiological, patient(with arrhythmia detection or alarms)

Device brand name · Mhx drt

Philips Information Center: medical device reports filed with FDA

249 reports name it, 2003–2020. Manufacturer given most often on reports: Philips Medical Systems. Product code MHX.

249
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
21.7%
classified as malfunction
82.1% across the product code
70.7%
classified as death, as reported
176 reports · not verified by FDA

FDA's MAUDE database holds 249 reports that name the brand "Philips Information Center" (mhx drt), received between May 2003 and December 2020; the manufacturer given most often on reports is Philips Medical Systems. Spellings of one product vary from report to report.

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 death (70.7%), malfunction (21.7%) and injury (6.8%); across all monitor, physiological, patient(with arrhythmia detection or alarms) reports (product code MHX) death is recorded in 5.9% and malfunction in 82.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device alarm system (25.3%), insufficient device problem information (14.5%) and no audible alarm (5.6%). The patient problems coded most often are death, cardiac arrest and bradycardia. 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

No report naming Philips Information Center was received in the five years to August 2026; the latest was received in December 2020.

By year received

027532003: 320032004: 52005: 920052006: 82007: 1020072008: 112009: 5320092010: 462011: 2820112012: 92013: 820132014: 42015: 820152017: 182018: 520182019: 122020: 122020

Event type and report source

Event type, as classified on the report

Death70.7%176
Injury6.8%17
Malfunction21.7%54
Other0.8%2
Not given0%0

Who filed the report

Manufacturer report100%249
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 32,636 reports carrying product code MHX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device alarm system6325.3%8.1%
Insufficient device problem information3614.5%1.3%
No audible alarm145.6%11.5%
No display/image83.2%4.1%
Device operates differently than expectedthe device behaved unexpectedly72.8%9.3%
Application program freezes or fails to launch52%1.5%
Defective alarm41.6%3.4%
Device displays incorrect message41.6%4.3%
Improper or incorrect procedure or method41.6%0.3%
Communication or transmission problemthe device could not communicate or transmit31.2%6%
Application interface becomes non-functional or program exits abnormally20.8%0.8%
Detachment of device component20.8%0.3%
Display or visual feedback problem20.8%3.2%
No device output20.8%1%
Alarm not visible10.4%0.6%
Alarm, audible10.4%0.1%
Battery problema problem with the battery10.4%0.2%
Data problem10.4%0.4%
Delayed alarm10.4%0.3%
Device inoperablethe device could not be used10.4%3.6%

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)ReportsShare
Deaththe patient died; cause not stated by this term11144.6%
Cardiac arrestthe heart stopped104%
Bradycardiaslow heart rate52%
Injurya physical injury31.2%
Low oxygen saturation31.2%
Cardiopulmonary arrest20.8%
Ventricular tachycardiaa fast rhythm from the lower heart chambers20.8%
Arrhythmia10.4%
Asystole10.4%
Chest painchest pain10.4%
Complete heart block10.4%
Distress10.4%
Falla fall10.4%
Loss of consciousnesspassing out10.4%
Myocardial infarctionheart attack10.4%

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

In context

MeasurePhilips Information CenterProduct code MHXAll MAUDE reports
Reports24932,63626,136,888
Share of that pool—0.8%0%
Classified as death, per 1,000 reports707599
Classified as injury6.8%11.2%36.2%
Classified as malfunction21.7%82.1%62.3%
Filed by the manufacturer100%93.4%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 MHX

BrandReportsLatest 12 monthsClassified as death
Patient Information Center iX1,94161910.4%
uCor Heart Failure and Arrhythmia Management System1,8777620%
Tempus Pro1,8501080.5%
Cns-6201a1,72000.8%
IntelliVue Multi Measurement Server X21,9241351.7%
Cns-6801a1,05801.5%
Intellivue Information Center Ix95207.5%
Intellivue X377701.5%
Tempus Pro, Printer5624000%
Piic Ix Hardware53804.6%
Xhibit Central Station4921540.8%
IntelliVue Multi-Measurement Module X34784011.7%
IntelliVue MX450 Patient Monitor4481237.6%
Pu-681ra4372221.4%
Cns-9700a39300.3%

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 Philips Information Center reports

How many FDA reports name Philips Information Center?

249 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

death (70.7%), malfunction (21.7%) and injury (6.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device alarm system (25.3%), insufficient device problem information (14.5%), no audible alarm (5.6%), no display/image (3.2%) and device operates differently than expected (2.8%). 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 Philips Information Center 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.