BIS 186-0195-GERecalls & reported problems
Covidien LP · BISX Module,Software Version 1.13,For use with GE Patient Monitors · Class 2
All models of BIS (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521129665), received between Feb 21, 2020 and Jul 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).
1 other recall cover devices cleared under the same FDA submission (K072286); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Incorrect Measurement1
- Material Split, Cut or Torn1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Device Damaged Prior to Use; Temperature Problem; Material Split, Cut or Torn; Device Damaged Prior to Use; Temperature Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING SERVICING, A HOST CABLE WAS DAMAGED, THE PATIENT INTERFACE CABLE HAD A GOUGE AND DID NOT MEET COSMETIC CRITERIA, THE CLAMP WAS BROKEN, THE BULKHEAD WAS CORRODED, AND THE PROTECTIVE SHIELD WAS BURNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22661013 ↗MalfunctionFeb 21, 2020Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD AN INACCURATE READINGS. THE MODULE WAS SWAPPED TO ISOLATE THE FAILURE. IT WAS STATED THAT THEY WERE ABLE TO PROCEED WITH THE SURGERY, WITH NO DELAY OR ILL EFFECT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9738585 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072286. One submission often covers many models, so check the product and lot details in each record.
- Z-2958-2018 · Jul 26, 2018 · Open, ClassifiedLi-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
Other Index-generating electroencephalograph software devices
- BIS 186-1046Covidien LP · Index-generating electroencephalograph software102 reports
- BIS 186-0224-AMSCovidien LP · Index-generating electroencephalograph software1 death41 reports
- BIS 186-0195-AMSCovidien LP · Index-generating electroencephalograph software38 reports
- BIS Module IntelliVue BIS ModulePhilips Medizin Systeme Böblingen GmbH · Index-Generating Electroencephalograph Software15 reports
- BIS 186-0195-NKCovidien LP · Index-generating electroencephalograph software11 reports
- BIS 186-1001-RFBCovidien LP · Index-generating electroencephalograph software6 reports
- BIS 186-0199-RFBCovidien LP · Index-generating electroencephalograph software5 reports
- BIS PMB4000Covidien LP · Index-generating electroencephalograph software5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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