Reported Reactions

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

Device brand name · Compact patient monitor

Mp50 Intellivue Patient Monitor: medical device reports filed with FDA

342 reports name it, 2009–2020. Manufacturer given most often on reports: Philips Medical Systems. Product code MHX.

342
device reports naming the brand
0% of all MAUDE reports · about 20 a year
0
reports, 12 months to August 2026
0 in the 12 months before
78.9%
classified as malfunction
82.1% across the product code
7%
classified as death, as reported
24 reports · not verified by FDA

342 medical device reports received by FDA name the brand "Mp50 Intellivue Patient Monitor" (compact patient monitor); the manufacturer given most often on reports is Philips Medical Systems; received from January 2009 to December 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (78.9%), injury (11.4%) and death (7%); 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 (30.7%), device operates differently than expected (17.3%) and device displays incorrect message (13.5%). The patient problems coded most often are death, low oxygen saturation and no patient involvement. 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 Mp50 Intellivue Patient Monitor was received in the five years to August 2026; the latest was received in December 2020.

By year received

031622009: 1920092010: 402011: 6220112012: 452013: 3720132014: 192015: 2620152016: 302017: 1920172018: 162019: 1520192020: 14

Event type and report source

Event type, as classified on the report

Death7%24
Injury11.4%39
Malfunction78.9%270
Other2.6%9
Not given0%0

Who filed the report

Manufacturer report100%342
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 system10530.7%8.1%
Device operates differently than expectedthe device behaved unexpectedly5917.3%9.3%
Device displays incorrect message4613.5%4.3%
No audible alarm4513.2%11.5%
Component falling267.6%0.9%
Breakthe device broke133.8%1.4%
Device inoperablethe device could not be used113.2%3.6%
Insufficient device problem information113.2%1.3%
Detachment of device component102.9%0.3%
No device output72%1%
No display/image61.8%4.1%
Defective alarm51.5%3.4%
No audible prompt/feedback51.5%3.5%
Display or visual feedback problem41.2%3.2%
Loss of powerthe device lost power41.2%1.1%
Therapeutic or diagnostic output failure41.2%0.5%
Alarm not visible30.9%0.6%
Communication or transmission problemthe device could not communicate or transmit30.9%6%
Defective devicethe device was defective30.9%0.4%
Device fell30.9%0.3%

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 term267.6%
Low oxygen saturation236.7%
No patient involvement185.3%
Cardiac arrestthe heart stopped92.6%
Injurya physical injury61.8%
Apnea20.6%
Cyanosis20.6%
Dyspneashortness of breath20.6%
Blood loss10.3%
Bone fracture(s)10.3%
Bradycardiaslow heart rate10.3%
Bruise/contusion10.3%
Collapse10.3%
Head injurya head injury10.3%
Laceration(s)10.3%

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

In context

MeasureMp50 Intellivue Patient MonitorProduct code MHXAll MAUDE reports
Reports34232,63626,136,888
Share of that pool—1%0%
Classified as death, per 1,000 reports70599
Classified as injury11.4%11.2%36.2%
Classified as malfunction78.9%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 Mp50 Intellivue Patient Monitor reports

How many FDA reports name Mp50 Intellivue Patient Monitor?

342 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?

malfunction (78.9%), injury (11.4%) and death (7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device alarm system (30.7%), device operates differently than expected (17.3%), device displays incorrect message (13.5%), no audible alarm (13.2%) and component falling (7.6%). 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 Mp50 Intellivue Patient Monitor 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.