Reported Reactions

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

Device brand name · Compact patient monitor

Mp30 Intellivue Patient Monitor: medical device reports filed with FDA

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

235
device reports naming the brand
0% of all MAUDE reports · about 14 a year
0
reports, 12 months to August 2026
0 in the 12 months before
75.7%
classified as malfunction
82.1% across the product code
14.9%
classified as death, as reported
35 reports · not verified by FDA

235 medical device reports received by FDA name the brand "Mp30 Intellivue Patient Monitor" (compact patient monitor); the manufacturer given most often on reports is Philips Medical Systems; received from March 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 (75.7%), death (14.9%) and injury (9.4%); 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 (23.4%), device displays incorrect message (13.2%) and device operates differently than expected (12.3%). The patient problems coded most often are death, no patient involvement and low oxygen saturation. 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 Mp30 Intellivue Patient Monitor was received in the five years to August 2026; the latest was received in December 2020.

By year received

019372009: 1420092010: 352011: 3720112012: 242013: 920132014: 142015: 2220152016: 232017: 1920172018: 132019: 1420192020: 11

Event type and report source

Event type, as classified on the report

Death14.9%35
Injury9.4%22
Malfunction75.7%178
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%235
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 system5523.4%8.1%
Device displays incorrect message3113.2%4.3%
Device operates differently than expectedthe device behaved unexpectedly2912.3%9.3%
Component falling2611.1%0.9%
No audible alarm229.4%11.5%
Device inoperablethe device could not be used135.5%3.6%
Breakthe device broke104.3%1.4%
Insufficient device problem information104.3%1.3%
No device output83.4%1%
Detachment of device component62.6%0.3%
Defective alarm52.1%3.4%
Defective devicethe device was defective52.1%0.4%
Defective component41.7%0.5%
No display/image41.7%4.1%
Alarm not visible20.9%0.6%
Output problem20.9%3.2%
Self-activation or keying20.9%0.4%
Application interface becomes non-functional or program exits abnormally10.4%0.8%
Connection problema connection problem10.4%0.3%
Cut in material10.4%0%

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 term3314%
No patient involvement125.1%
Low oxygen saturation104.3%
Cardiac arrestthe heart stopped52.1%
Injurya physical injury31.3%
Apnea20.9%
Arrhythmia20.9%
Electric shockan electric shock20.9%
Loss of pulse20.9%
Bone fracture(s)10.4%
Bradycardiaslow heart rate10.4%
Bruise/contusion10.4%
Loss of consciousnesspassing out10.4%
Low blood pressure/ hypotension10.4%
Malaisegeneral feeling of being unwell10.4%

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

In context

MeasureMp30 Intellivue Patient MonitorProduct code MHXAll MAUDE reports
Reports23532,63626,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports149599
Classified as injury9.4%11.2%36.2%
Classified as malfunction75.7%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 Mp30 Intellivue Patient Monitor reports

How many FDA reports name Mp30 Intellivue Patient Monitor?

235 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 (75.7%), death (14.9%) and injury (9.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device alarm system (23.4%), device displays incorrect message (13.2%), device operates differently than expected (12.3%), component falling (11.1%) and no audible alarm (9.4%). 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 Mp30 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.