Monitor, physiological, patient(with arrhythmia detection or alarms): medical device reports filed with FDA

32,636 reports carry this product code, 1992–2026; 30 brands with a page.

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.

32,636
reports with this product code: 0.1% of all MAUDE reports; 4,913
reports, 12 months to August 2026: 3,264 in the 12 months before; 82.1%
classified as malfunction: 62.3% across all reports; 5.9%
classified as death, as reported: 0.9% across all reports

Product code MHX is FDA's classification for "Monitor, physiological, patient(with arrhythmia detection or alarms)" (cardiovascular panel), a class 2 device. 32,636 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1992 to August 2026.

4,913 reports arrived in the 12 months to August 2026, up 51% from 3,264 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 (82.1%), injury (11.2%) and death (5.9%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Patient Information Center iX	1,940	619	10.4%	82.9%
uCor Heart Failure and Arrhythmia Management System	1,877	762	0%	0%
Tempus Pro	1,850	108	0.5%	98.4%
Cns-6201a	1,720	0	0.8%	98.8%
IntelliVue Multi Measurement Server X2	1,355	135	1.7%	94.7%
Cns-6801a	1,058	0	1.5%	98.4%
Intellivue Information Center Ix	952	0	7.5%	85.5%
Intellivue X3	776	0	1.5%	93.2%
Tempus Pro, Printer	562	400	0%	99.6%
Piic Ix Hardware	538	0	4.6%	90.1%
Xhibit Central Station	492	154	0.8%	98.8%
IntelliVue Multi-Measurement Module X3	476	401	1.7%	93.5%
IntelliVue MX450 Patient Monitor	448	123	7.6%	84.8%
Pu-681ra	437	222	1.4%	98.6%
Cns-9700a	393	0	0.3%	98.7%
Arrhythmia Management System	381	4	0%	0%
Panorama Central Station With Telemetry	357	0	0.8%	98.1%
Passport 2 Monitor	351	0	0.2%	99.4%
Panorama Central Station With Telepack	346	0	0%	99.7%
Mp50 Intellivue Patient Monitor	342	0	7%	78.9%
IntelliVue MX40 1.4GHz	333	297	2%	96.3%
IntelliVue MX800 patient monitor	328	54	10.6%	74.5%
Panorama Central Station	301	0	2.2%	94.3%
Intellivue Info Center Ix	290	0	9%	89.7%
Pic Ix Hardware	277	0	10.4%	82.7%
IntelliVue MX550 Patient Monitor	257	82	5.4%	82.1%
Cns-6201	248	0	0.8%	98.4%
Mp30 Intellivue Patient Monitor	235	0	14.9%	75.7%
Tempus Pro, Printer, IBP	230	187	0%	100%
Cns-9700	226	0	1.8%	94.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Philips Medical Systems	9,221	28.3%
Nihon Kohden	5,603	17.2%
Philips Medizin Systeme B Blingen	3,792	11.6%
Remote Diagnostic Technologies	2,715	8.3%
Mindray Ds USA	2,366	7.2%
Zoll Manufacturing	2,260	6.9%
Spacelabs Healthcare	1,350	4.1%
Philips North America	874	2.7%
Draeger Medical Systems	617	1.9%
Ge Healthcare	578	1.8%
Philips Healthcare	164	0.5%
Datascope	139	0.4%
Welch Allyn	65	0.2%
Welch Allyn Protocol	60	0.2%
Agilent Technologies	24	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 and report source

Event type

Death5.9%1,917

Injury11.2%3,655

Malfunction82.1%26,787

Other0.5%151

Not given0.4%126

Who filed

Manufacturer report93.4%30,472

Voluntary report1.3%440

User facility report0%0

Distributor report3.1%1,023

Not given2.1%701

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
No audible alarm	3,741	11.5%
Device operates differently than expectedthe device behaved unexpectedly	3,051	9.3%
Device alarm system	2,645	8.1%
Communication or transmission problemthe device could not communicate or transmit	1,952	6%
Patient device interaction problem	1,943	6%
Device displays incorrect message	1,419	4.3%
No display/image	1,350	4.1%
Device inoperablethe device could not be used	1,174	3.6%
No audible prompt/feedback	1,126	3.5%
Defective alarm	1,116	3.4%
Display or visual feedback problem	1,054	3.2%
Output problem	1,029	3.2%
Application program problem	888	2.7%
Nonstandard device	836	2.6%
Unable to obtain readings	745	2.3%
Unintended application program shut down	620	1.9%
Computer operating system problem	607	1.9%
Incorrect measurementthe device measured wrongly	555	1.7%
Power problem	519	1.6%
Wireless communication problema wireless connection problem	496	1.5%

Questions about monitor, physiological, patient(with arrhythmia detection or alarms) reports

What is product code MHX?

FDA's classification code for "Monitor, physiological, patient(with arrhythmia detection or alarms)", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

32,636 reports through August 2026, 4,913 of them in the latest 12 months.

Which brands appear most often?

Patient Information Center iX (1,940), uCor Heart Failure and Arrhythmia Management System (1,877), Tempus Pro (1,850), Cns-6201a (1,720) and IntelliVue Multi Measurement Server X2 (1,355). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.