Devices › Index-generating electroencephalograph software
Device brand name · Index-generating electroencephalograph softwar
Bis: medical device reports filed with FDA
439 reports name it, 2017–2026. Manufacturer given most often on reports: Covidien. Product code OLW.
- 439
- device reports naming the brand
- 0% of all MAUDE reports · about 49 a year
- 113
- reports, 12 months to August 2026
- 100 in the 12 months before
- 95.2%
- classified as malfunction
- 95.7% across the product code
- 0.5%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 439 reports that name the brand "Bis" (index-generating electroencephalograph softwar), received between July 2017 and August 2026; the manufacturer given most often on reports is Covidien. Spellings of one product vary from report to report.
113 reports arrived in the 12 months to August 2026, up 13% from 100 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 (95.2%), injury (4.3%) and death (0.5%); across all index-generating electroencephalograph software reports (product code OLW) death is recorded in 0.3% and malfunction in 95.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect measurement (34.6%), high readings (13.7%) and patient device interaction problem (12.5%). The patient problems coded most often are pressure sore/ulcer, skin inflammation/ irritation and no patient involvement. 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 347 reports carrying product code OLW. 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 |
|---|---|---|---|
| Incorrect measurementthe device measured wrongly | 152 | 34.6% | 41.5% |
| High readingsreadings were too high | 60 | 13.7% | 16.1% |
| Patient device interaction problem | 55 | 12.5% | 1.7% |
| Temperature problem | 54 | 12.3% | 15.6% |
| Low readingsreadings were too low | 48 | 10.9% | 9.5% |
| Image display error/artifact | 31 | 7.1% | 6.9% |
| Unable to obtain readings | 24 | 5.5% | 1.7% |
| Device damaged prior to usethe device was damaged before use | 23 | 5.2% | 6.6% |
| Device alarm system | 22 | 5% | 6.1% |
| Communication or transmission problemthe device could not communicate or transmit | 19 | 4.3% | 2.6% |
| Material split, cut or torn | 11 | 2.5% | 3.2% |
| Failure to power up | 10 | 2.3% | 2.9% |
| Erratic or intermittent display | 8 | 1.8% | 1.4% |
| Failure to run on battery | 7 | 1.6% | 2% |
| Display or visual feedback problem | 5 | 1.1% | 1.2% |
| Connection problema connection problem | 4 | 0.9% | 1.2% |
| Defective component | 4 | 0.9% | 0.6% |
| Failure to analyze signal | 4 | 0.9% | 0.9% |
| Incorrect, inadequate or imprecise result or readings | 4 | 0.9% | 2.9% |
| Computer software problema software problem | 3 | 0.7% | 0.9% |
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 |
|---|---|---|
| Pressure sore/ulcer | 11 | 2.5% |
| Skin inflammation/ irritation | 11 | 2.5% |
| No patient involvement | 7 | 1.6% |
| Oversedation | 7 | 1.6% |
| Awareness during anesthesia | 6 | 1.4% |
| Burn(s)a burn | 6 | 1.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 1.1% |
| Erythemaskin redness | 5 | 1.1% |
| Injurya physical injury | 5 | 1.1% |
| Skin irritationirritated skin | 5 | 1.1% |
| Inflammationinflammation | 4 | 0.9% |
| Skin erosion | 4 | 0.9% |
| Skin discoloration | 3 | 0.7% |
| Bruise/contusion | 2 | 0.5% |
| Device overstimulation of tissue | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bis | Product code OLW | All MAUDE reports |
|---|---|---|---|
| Reports | 439 | 347 | 26,136,888 |
| Share of that pool | — | 126.5% | 0% |
| Classified as death, per 1,000 reports | 5 | 3 | 9 |
| Classified as injury | 4.3% | 4% | 36.2% |
| Classified as malfunction | 95.2% | 95.7% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.4% | 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."
Questions about Bis reports
How many FDA reports name Bis?
439 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 113 in the latest 12 months.
What kinds of events are reported?
malfunction (95.2%), injury (4.3%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect measurement (34.6%), high readings (13.7%), patient device interaction problem (12.5%), temperature problem (12.3%) and low readings (10.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bis 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.