BIS 186-0195-DMRecalls & reported problems
Covidien LP · BISX Module,Software Version 1.13,For use with Drager 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521129726), received between Nov 22, 2019 and Nov 7, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Power Up” (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
- Appropriate Device Problem Term/Code Not Available1
- Failure to Power Up1
- Incorrect Measurement1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE MEASURED IMPLAUSIBLE VALUES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627287 ↗InjuryNov 22, 2019Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING USE, THE UNIT WOULD NOT WORK PROPERLY. IT WAS INDICATED THAT IT RESULTED IN A DELAY OF THE PROCEDURE/SURGERY.
Patient problems: Injury
MAUDE report 9364849 ↗
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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