Device manufacturer, as written on reports

Nihon Kohden: medical device reports filed with FDA

7,344 reports name it as the manufacturer of the device involved, 1996–2026.

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.

7,344
reports naming it as manufacturer: 0% of all MAUDE reports; 850
reports, 12 months to August 2026: 425 in the 12 months before; 98%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

7,344 medical device reports received by FDA give Nihon Kohden as the manufacturer of the device involved, 0% of the MAUDE database, from March 1996 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

850 reports arrived in the 12 months to August 2026, up 100% from 425 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%), death (1.1%) and injury (0.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Cns-6201a	Monitor, physiological, patient(with arrhythmia detection or alarms)	1,615	0	0.8%
Cns-6801a	Monitor, physiological, patient(with arrhythmia detection or alarms)	1,058	0	1.5%
Pu-681ra	Monitor, physiological, patient(with arrhythmia detection or alarms)	437	222	1.4%
Cns-9700a	Monitor, physiological, patient(with arrhythmia detection or alarms)	304	0	0.3%
Org-9110a	Transmitters and receivers, physiological signal, radiofrequency	301	59	0%
Gf-210ra	Analyzer, gas, carbon-dioxide, gaseous-phase	261	0	0%
Ni	Set, administration, for peritoneal dialysis, disposable	230	1,587	1.8%
Cns-6201	Monitor, physiological, patient(with arrhythmia detection or alarms)	184	0	0.8%
Zm-531pa	Monitor, cardiac (incl. cardiotachometer & rate alarm)	175	38	1.1%
Gf-210r	Analyzer, gas, carbon-dioxide, gaseous-phase	171	95	0%
Cns-9700	Monitor, physiological, patient(with arrhythmia detection or alarms)	161	0	1.8%
Ag-920ra	Analyzer, gas, carbon-dioxide, gaseous-phase	112	0	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	5,603	76.3%
CCK	Analyzer, gas, carbon-dioxide, gaseous-phase	561	7.6%
DRT	Monitor, cardiac (incl. cardiotachometer & rate alarm)	529	7.2%
DRG	Transmitters and receivers, physiological signal, radiofrequency	497	6.8%
GWF	Stimulator, electrical, evoked response	102	1.4%
GWQ	Full-montage standard electroencephalograph	16	0.2%
DXN	System, measurement, blood-pressure, non-invasive	10	0.1%
DPS	Electrocardiograph	5	0.1%
LDD	Dc-defibrillator, low-energy, (including paddles)	2	0%
BZA	Connector, airway (extension)	1	0%

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

Death1.1%83

Injury0.7%55

Malfunction98%7,198

Other0.1%4

Not given0.1%4

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Nihon Kohden reports

How many FDA device reports name Nihon Kohden as manufacturer?

7,344 reports through August 2026, 850 of them in the latest 12 months.

Which of its brands appear most often?

Cns-6201a (1,615), Cns-6801a (1,058), Pu-681ra (437), Cns-9700a (304) and Org-9110a (301).

Which device types does it report on?

monitor, physiological, patient(with arrhythmia detection or alarms) (76.3%), analyzer, gas, carbon-dioxide, gaseous-phase (7.6%), monitor, cardiac (incl. cardiotachometer & rate alarm) (7.2%) and transmitters and receivers, physiological signal, radiofrequency (6.8%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.