Gas-machine, anesthesia: medical device reports filed with FDA

48,583 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.

48,583
reports with this product code: 0.2% of all MAUDE reports; 8,590
reports, 12 months to August 2026: 8,356 in the 12 months before; 97.9%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code BSZ is FDA's classification for "Gas-machine, anesthesia" (anesthesiology panel), a class 2 device. 48,583 medical device reports carry this product code, 0.2% of the MAUDE database, from July 1992 to August 2026.

8,590 reports arrived in the 12 months to August 2026, close to the 8,356 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 (97.9%), injury (1.5%) and other (0.3%). 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
Carestation 650	6,152	1,686	0%	99.8%
Avance	5,972	1,353	0.1%	99.2%
Aisys	5,273	1,531	0.1%	98.7%
Carestation 620	4,352	1,402	0%	99.9%
Aisys Cs2	3,105	4	0.1%	99.1%
Avance Cs2	2,937	3	0.2%	99.2%
Aespire 7100	2,777	3	0.1%	99.8%
Carestation 750	2,540	1,042	0%	99.8%
Aespire 7900	2,039	11	0.2%	99.6%
Aespire View	1,729	10	0.1%	99.5%
Aespire	1,362	564	0.1%	99.4%
Aestiva 7900	1,160	2	0%	99.6%
Aestiva 7100	860	0	0%	99.5%
Aestiva	789	329	0.1%	98.2%
Flow-I	581	0	0%	91.9%
Carestation 650 A1	479	10	0%	100%
Aestiva Mri	464	4	0.2%	98.7%
Apollo	425	141	1.8%	84.1%
Primus	424	42	1.9%	88.3%
Flow-i C20	391	55	0%	94.4%
Carestation 620 A1	247	0	0%	100%
Narkomed	226	0	5.3%	72.7%
Adu	224	0	0%	96.9%
Perseus A500	213	42	2.1%	88.6%
Fabius GS	195	7	1.6%	87.4%
Fabius Tiro	189	28	1%	95.7%
Fabius GS Premium	157	19	1.1%	93.7%
Kion	135	0	0%	96.3%
Evita	102	0	7.1%	86.8%
Carescape R860	30	50	0.2%	99.2%

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
Datex-Ohmeda	32,142	66.2%
Ge Medical Systems China Wuxi	8,483	17.5%
Ge Medical Systems China	2,212	4.6%
Maquet Critical Care	1,469	3%
Draeger Medical	516	1.1%
Mindray Ds USA	213	0.4%
Ge Healthcare	128	0.3%
Spacelabs Healthcare	79	0.2%
Draeger Medical Systems	48	0.1%
Ge Medical Systems	27	0.1%
Datascope	6	0%
Abbott Laboratories	1	0%
Bard Access Systems	1	0%
Dentsply Tulsa	1	0%
Maquet	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 and report source

Event type

Death0.2%113

Injury1.5%726

Malfunction97.9%47,545

Other0.3%125

Not given0.2%74

Who filed

Manufacturer report98%47,606

Voluntary report1%479

User facility report0%0

Distributor report0.2%79

Not given0.9%419

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

Device problems coded

Device problem (FDA code)	Reports	Share
Therapeutic or diagnostic output failure	7,158	14.7%
Mechanical problema mechanical problem	4,815	9.9%
No flow	4,293	8.8%
Failure to run on battery	4,053	8.3%
Insufficient flow or under infusion	2,582	5.3%
Device operates differently than expectedthe device behaved unexpectedly	1,790	3.7%
No display/image	1,775	3.7%
Power problem	1,685	3.5%
Electrical /electronic property probleman electrical or electronic problem	1,460	3%
Unexpected therapeutic results	1,447	3%
Failure to deliverthe device did not deliver the dose or item	1,407	2.9%
Gas/air leak	1,336	2.7%
Output problem	1,291	2.7%
Gas output problem	1,124	2.3%
Increase in pressure	1,101	2.3%
Unexpected shutdown	956	2%
Device displays incorrect message	853	1.8%
Infusion or flow problema problem with flow or infusion	803	1.7%
Leak/splashthe device leaked	773	1.6%
Device alarm system	714	1.5%

Questions about gas-machine, anesthesia reports

What is product code BSZ?

FDA's classification code for "Gas-machine, anesthesia", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

48,583 reports through August 2026, 8,590 of them in the latest 12 months.

Which brands appear most often?

Carestation 650 (6,152), Avance (5,972), Aisys (5,273), Carestation 620 (4,352) and Aisys Cs2 (3,105). 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.