Cns-6201: medical device reports filed with FDA

249 reports name it, 2014–2015. Manufacturer given most often on reports: Nihon Kohden. Product code MHX.

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.

249
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; 98.4%
classified as malfunction: 82.1% across the product code; 0.8%
classified as death, as reported: 2 reports · not verified by FDA

FDA's MAUDE database holds 249 reports that name the brand "Cns-6201" (central monitor system), received between May 2014 and September 2015; the manufacturer given most often on reports is Nihon Kohden. 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 malfunction (98.4%) and death (0.8%); 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 inoperable (81.5%), device stops intermittently (7.2%) and no display/image (4%). The patient problems coded most often are death. 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 Cns-6201 was received in the five years to August 2026; the latest was received in September 2015.

Event type and report source

Event type, as classified on the report

Death0.8%2

Injury0%0

Malfunction98.4%245

Other0%0

Not given0.8%2

Who filed the report

Manufacturer report52.6%131

Voluntary report0%0

User facility report0%0

Distributor report47.4%118

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)	Reports	Share	Share across product code
Device inoperablethe device could not be used	203	81.5%	3.6%
Device stops intermittentlythe device stopped now and then	18	7.2%	0.7%
No display/image	10	4%	4.1%
Communication or transmission problemthe device could not communicate or transmit	8	3.2%	6%
Device operates differently than expectedthe device behaved unexpectedly	6	2.4%	9.3%
No audible alarm	6	2.4%	11.5%
Device alarm system	5	2%	8.1%
Application interface becomes non-functional or program exits abnormally	2	0.8%	0.8%
Delayed alarm	2	0.8%	0.3%
Device displays incorrect message	2	0.8%	4.3%
Failure to service	2	0.8%	0%
Inadequate service	2	0.8%	0%
Wireless communication problema wireless connection problem	2	0.8%	1.5%
Breakthe device broke	1	0.4%	1.4%
Computer operating system problem	1	0.4%	1.9%
Failure to power up	1	0.4%	0.7%
Image display error/artifact	1	0.4%	0.3%
Noise, audible	1	0.4%	0.2%
Operating system becomes nonfunctional	1	0.4%	0.6%

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)	Reports	Share
Deaththe patient died; cause not stated by this term	2	0.8%

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

In context

Measure	Cns-6201	Product code MHX	All MAUDE reports
Reports	249	32,636	26,136,888
Share of that pool	—	0.8%	0%
Classified as death, per 1,000 reports	8	59	9
Classified as injury	0%	11.2%	36.2%
Classified as malfunction	98.4%	82.1%	62.3%
Filed by the manufacturer	52.6%	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

Brand	Reports	Latest 12 months	Classified as death
Patient Information Center iX	1,941	619	10.4%
uCor Heart Failure and Arrhythmia Management System	1,877	762	0%
Tempus Pro	1,850	108	0.5%
Cns-6201a	1,720	0	0.8%
IntelliVue Multi Measurement Server X2	1,924	135	1.7%
Cns-6801a	1,058	0	1.5%
Intellivue Information Center Ix	952	0	7.5%
Intellivue X3	777	0	1.5%
Tempus Pro, Printer	562	400	0%
Piic Ix Hardware	538	0	4.6%
Xhibit Central Station	492	154	0.8%
IntelliVue Multi-Measurement Module X3	478	401	1.7%
IntelliVue MX450 Patient Monitor	448	123	7.6%
Pu-681ra	437	222	1.4%
Cns-9700a	393	0	0.3%

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 Cns-6201 reports

How many FDA reports name Cns-6201?

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?

malfunction (98.4%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device inoperable (81.5%), device stops intermittently (7.2%), no display/image (4%), communication or transmission problem (3.2%) and device operates differently than expected (2.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (52.6%) and distributor reports (47.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Cns-6201 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.