Devices › Gas-machine, anesthesia
Device brand name · Anesthesia gas machine
Aisys: medical device reports filed with FDA
5,275 reports name it, 2006–2026. Manufacturer given most often on reports: Datex-Ohmeda. Product code BSZ.
- 5,275
- device reports naming the brand
- 0% of all MAUDE reports · about 265 a year
- 1,531
- reports, 12 months to August 2026
- 1,211 in the 12 months before
- 98.7%
- classified as malfunction
- 97.9% across the product code
- 0.1%
- classified as death, as reported
- 7 reports · not verified by FDA
5,275 medical device reports received by FDA name the brand "Aisys" (anesthesia gas machine); the manufacturer given most often on reports is Datex-Ohmeda; received from August 2006 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,531 reports arrived in the 12 months to August 2026, up 26% from 1,211 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 (98.7%), injury (1%) and death (0.1%); across all gas-machine, anesthesia reports (product code BSZ) death is recorded in 0.2% and malfunction in 97.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient flow or under infusion (16.2%), therapeutic or diagnostic output failure (13.7%) and mechanical problem (11.5%). The patient problems coded most often are no patient involvement, low oxygen saturation and awareness during anesthesia. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 48,583 reports carrying product code BSZ. 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 |
|---|---|---|---|
| Insufficient flow or under infusion | 857 | 16.2% | 5.3% |
| Therapeutic or diagnostic output failure | 725 | 13.7% | 14.7% |
| Mechanical problema mechanical problem | 605 | 11.5% | 9.9% |
| No display/image | 304 | 5.8% | 3.7% |
| Electrical /electronic property probleman electrical or electronic problem | 268 | 5.1% | 3% |
| Unexpected therapeutic results | 257 | 4.9% | 3% |
| Failure to run on battery | 248 | 4.7% | 8.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 211 | 4% | 3.7% |
| Power problem | 202 | 3.8% | 3.5% |
| Gas/air leak | 146 | 2.8% | 2.7% |
| Unexpected shutdown | 119 | 2.3% | 2% |
| Infusion or flow problema problem with flow or infusion | 112 | 2.1% | 1.7% |
| Leak/splashthe device leaked | 97 | 1.8% | 1.6% |
| Increase in pressure | 91 | 1.7% | 2.3% |
| No flow | 88 | 1.7% | 8.8% |
| Failure to power up | 68 | 1.3% | 1.2% |
| Device alarm system | 63 | 1.2% | 1.5% |
| Device displays incorrect message | 59 | 1.1% | 1.8% |
| Improper flow or infusion | 54 | 1% | 0.6% |
| Pressure problem | 42 | 0.8% | 1.3% |
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 |
|---|---|---|
| No patient involvement | 605 | 11.5% |
| Low oxygen saturation | 25 | 0.5% |
| Awareness during anesthesia | 8 | 0.2% |
| Cardiac arrestthe heart stopped | 6 | 0.1% |
| Deaththe patient died; cause not stated by this term | 5 | 0.1% |
| Burn(s)a burn | 4 | 0.1% |
| Low blood pressure/ hypotension | 3 | 0.1% |
| Cyanosis | 2 | 0% |
| High blood pressure/ hypertension | 2 | 0% |
| Manual ventilation required | 2 | 0% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Bradycardiaslow heart rate | 1 | 0% |
| Brain damage | 1 | 0% |
| Brain injury | 1 | 0% |
| Burn, thermal | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Aisys | Product code BSZ | All MAUDE reports |
|---|---|---|---|
| Reports | 5,275 | 48,583 | 26,136,888 |
| Share of that pool | — | 10.9% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 1% | 1.5% | 36.2% |
| Classified as malfunction | 98.7% | 97.9% | 62.3% |
| Filed by the manufacturer | 99.4% | 98% | 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 BSZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Carestation 650 | 6,160 | 1,686 | 0% |
| Avance | 5,977 | 1,353 | 0.1% |
| Carestation 620 | 4,356 | 1,402 | 0% |
| Aisys Cs2 | 3,105 | 4 | 0.1% |
| Avance Cs2 | 2,945 | 3 | 0.2% |
| Aespire 7100 | 2,778 | 3 | 0.1% |
| Carestation 750 | 2,541 | 1,042 | 0% |
| Aespire 7900 | 2,049 | 11 | 0.2% |
| Aespire View | 1,729 | 10 | 0.1% |
| Aespire | 1,363 | 564 | 0.1% |
| Aestiva 7900 | 2,521 | 2 | 0% |
| Aestiva 7100 | 871 | 0 | 0% |
| Aestiva | 794 | 329 | 0.1% |
| Flow-I | 582 | 0 | 0% |
| Carestation 650 A1 | 479 | 10 | 0% |
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 Aisys reports
How many FDA reports name Aisys?
5,275 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,531 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%), injury (1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient flow or under infusion (16.2%), therapeutic or diagnostic output failure (13.7%), mechanical problem (11.5%), no display/image (5.8%) and electrical /electronic property problem (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Aisys 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.