Device manufacturer, as written on reports

Datex-Ohmeda: medical device reports filed with FDA

53,973 reports name it as the manufacturer of the device involved, 1998–2026.

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.

53,973
reports naming it as manufacturer: 0.2% of all MAUDE reports; 8,704
reports, 12 months to August 2026: 9,174 in the 12 months before; 99.1%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

53,973 medical device reports received by FDA give Datex-Ohmeda as the manufacturer of the device involved, 0.2% of the MAUDE database, from June 1998 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

8,704 reports arrived in the 12 months to August 2026, close to the 9,174 of 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 (99.1%), injury (0.6%) and death (0.1%). 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
Avance	Gas-machine, anesthesia	5,949	1,353	0.1%
Aisys	Gas-machine, anesthesia	5,240	1,531	0.1%
Carescape R860	Ventilator, continuous, facility use	4,136	50	0.2%
Carescape	Ventilator, continuous, facility use	3,908	2,289	0.1%
Engstrom	Ventilator, continuous, facility use	3,179	304	0.2%
Aisys Cs2	Gas-machine, anesthesia	3,076	4	0.1%
Avance Cs2	Gas-machine, anesthesia	2,929	3	0.2%
Tec	Vaporizer, anesthesia, non-heated	2,779	879	0%
Aestiva 7900	Ventilator, continuous, facility use	2,508	2	0%
Panda iRes Warmer	Warmer, infant radiant	2,427	13	0%
Aespire 7100	Gas-machine, anesthesia	2,092	3	0.1%
Aespire 7900	Gas-machine, anesthesia	2,040	11	0.2%
Carestation 650	Gas-machine, anesthesia	1,791	1,686	0%
Aespire View	Gas-machine, anesthesia	1,718	10	0.1%
Carestation 620	Gas-machine, anesthesia	1,493	1,402	0%
Aespire	Gas-machine, anesthesia	1,228	564	0.1%
Aestiva 7100	Gas-machine, anesthesia	865	0	0%
Giraffe Warmer	Warmer, infant radiant	833	14	0%
Aestiva	Gas-machine, anesthesia	786	329	0.1%
Carestation 750	Gas-machine, anesthesia	721	1,042	0%
Tec 6 Plus	Vaporizer, anesthesia, non-heated	581	86	0%
Aestiva Mri	Gas-machine, anesthesia	461	4	0.2%
Ivent 201	Ventilator, continuous, facility use	373	3	1.7%
Tec 7	Vaporizer, anesthesia, non-heated	266	80	0%
Engstrom Cs	Ventilator, continuous, facility use	237	7	0.4%
Tec 6	Vaporizer, anesthesia, non-heated	229	0	0%
Giraffe OmniBed Carestation	Incubator, neonatal	176	108	0.3%
Giraffe IRS	Warmer, infant radiant	158	54	0%
Carestation 620 A1	Gas-machine, anesthesia	59	0	0%
Carestation 650 A1	Gas-machine, anesthesia	56	10	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
BSZ	Gas-machine, anesthesia	32,142	59.6%
CBK	Ventilator, continuous, facility use	13,512	25%
CAD	Vaporizer, anesthesia, non-heated	4,150	7.7%
FMT	Warmer, infant radiant	3,754	7%
FMZ	Incubator, neonatal	303	0.6%
MRN	Apparatus, nitric oxide delivery	41	0.1%
BTL	Ventilator, emergency, powered (resuscitator)	32	0.1%
DQA	Oximeter	8	0%
CFR	Hexokinase, glucose	6	0%
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	4	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

Death0.1%76

Injury0.6%311

Malfunction99.1%53,514

Other0.1%47

Not given0%25

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

Questions about Datex-Ohmeda reports

How many FDA device reports name Datex-Ohmeda as manufacturer?

53,973 reports through August 2026, 8,704 of them in the latest 12 months.

Which of its brands appear most often?

Avance (5,949), Aisys (5,240), Carescape R860 (4,136), Carescape (3,908) and Engstrom (3,179).

Which device types does it report on?

gas-machine, anesthesia (59.6%), ventilator, continuous, facility use (25%), vaporizer, anesthesia, non-heated (7.7%) and warmer, infant radiant (7%).

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.