BIS 186-0224-PHRecalls & reported problems
Covidien LP · BISX4 Module Software Version 1.15. For use with Philips Patient Monitors · Class 2
All models of BIS (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521533059), received between Mar 2, 2023 and Mar 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Temperature Problem” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023Temperature Problem; Temperature Problem
ACCORDING TO THE REPORTER, THE DEVICE GOT EXTREMELY HOT DURING USE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16468978 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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