BIS 186-0195-AMSRecalls & reported problems
Covidien LP · BISX Module,Software Version 1.15,For use with BIS Complete Monitors · Class 2
All models of BIS (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien BISX module is software used with BIS monitors to interpret brain activity during anesthesia. Reports mostly describe incorrect or unusual readings; one report mentions a patient becoming aware during a procedure despite a monitor reading. There are 37 reports, with no deaths and no injuries, and no recalls name this device. Reports fell from 13 in the previous 12 months to 2 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521129832), received between Jul 26, 2017 and Sep 22, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (19 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement19
- Temperature Problem6
- Device Damaged Prior to Use5
- High Readings5
- Low Readings4
- Defective Component2
- Image Display Error/Artifact2
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information13
- Awareness During Anesthesia1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Oversedation1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Incorrect Measurement
Patient problems: Insufficient Information
MAUDE report 50860275 ↗MalfunctionJun 1, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE MONITOR HAD A READING OF 43, HOWEVER, THE PATIENT EXPERIENCED AN EPISODE OF INTRAOPERATIVE AWARENESS. FAILURE WAS ISOLATED TO THE MONITOR. IT WAS ALSO REPORTED THAT THE MODULE ALLEGEDLY WAS USED DURING THE PROCEDURE, HOWEVER IT DISPLAYED A DIFFERENT SERIAL NUMBER ON THE THE MONITOR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348616 ↗MalfunctionDec 20, 2025Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE DID NOT MEASURE CORRECTLY DURING USE. THERE WERE NO AUDIBLE AND VISUAL ALARMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858442 ↗MalfunctionOct 17, 2025High Readings; High Readings
IT WAS REPORTED THAT THE DEVICE DISPLAYED ADEQUATE BURST SUPPRESSION, BUT THE BIS VALUE REMAINED BETWEEN 85 AND 95 DURING PRE-OPERATIVE PREPARATION. TESTING WAS CONDUCTED USING ANOTHER POD, WHICH SHOWED A BIS READING OF 25. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23329825 ↗MalfunctionSep 18, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE MODULE GAVE INCORRECT DATA. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23082820 ↗MalfunctionSep 11, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT READ CORRECTLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027747 ↗MalfunctionMay 9, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT PRIOR TO USE, THERE WERE INCORRECT READINGS OBSERVED ON AN ELECTROCARDIOGRAM UPON CHECKING THE INDICATED MODULE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997143 ↗MalfunctionMar 7, 2025Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings
IT WAS REPORTED THAT A DEVICE DID NOT READ PROPERLY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21546213 ↗MalfunctionFeb 13, 2025Use of Device Problem; Low Readings; Use of Device Problem; Low Readings
IT WAS REPORTED THAT THE EEG READING WAS 30-50 THROUGHOUT THE PROCEDURE BUT THE PATIENT SUDDENLY MOVED, SAT UP THEN LAY BACK DOWN WHICH OCCURRED WITHIN 15 SECONDS. THE ANESTHETIC TEAM MANAGED THE SITUATION PROMPTLY. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Awareness During Anesthesia
MAUDE report 21375039 ↗MalfunctionJan 17, 2025Incorrect Measurement; Defective Component; Incorrect Measurement; Defective Component
IT WAS REPORTED THAT, DURING USE, THE DEVICE HAD NOISE CONTAMINATION AND THE SIGNAL WAS NOT ACCURATE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178315 ↗MalfunctionJan 10, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT PRIOR TO USE, THE UNIT DID NOT GIVE THE CORRECT SIGNAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129891 ↗MalfunctionJan 9, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE WAS NOT READING CORRECTLY ON THE MONITOR DURING PRE-OPERATIVE PREPARATION FOR USE. THE USER ATTEMPTED TO TROUBLESHOOT BY TESTING THE DEVICE ON ANOTHER MONITOR, WHICH READ CORRECTLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118476 ↗MalfunctionNov 14, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER PRIOR TO USE, THE UNIT HAD INCORRECT READINGS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20688678 ↗MalfunctionNov 12, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD NO RELIABLE READINGS. IT WAS CHECKED PRIOR TO USE ON PATIENT BUT THE SPECIFIC READINGS AND HOW IT WAS OBTAINED WAS NOT KNOWN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20665120 ↗MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE MODULE WAS NOT DISPLAYING THE CORRECT DATA. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651043 ↗MalfunctionNov 7, 2024Incorrect Measurement; Device Damaged Prior to Use; Incorrect Measurement; Device Damaged Prior to Use
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD VERY SLIGHT IMPACT DAMAGE AND GIVING INACCURATE READINGS AND TRANSDUCER WAS ALSO TO BE CHECKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20628712 ↗MalfunctionOct 24, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE'S LOC 2 WAS NOT TAKING READINGS CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 20523625 ↗MalfunctionAug 14, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE MODULE DID NOT MEASURE WELL. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19981210 ↗MalfunctionFeb 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE DID NOT MEASURE CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18661204 ↗MalfunctionFeb 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD NO RELIABLE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18658960 ↗MalfunctionFeb 5, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE DEVICE HAD WRONG MEASUREMENTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18639295 ↗MalfunctionFeb 5, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER THE DEVICE WOULD NOT MARK CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18639153 ↗MalfunctionFeb 1, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT'S MEASUREMENT WERE INCORRECT. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18623894 ↗MalfunctionSep 30, 2022Erratic or Intermittent Display; Image Display Error/Artifact; Erratic or Intermittent Display; Image Display Error/Artifact
ACCORDING TO THE REPORTER, THE UNIT DISPLAYED ERROR CODE "226030" AND UNRELIABLE READING. THE BIS READING WENT FROM 30 TO 99, AND THEN WENT BACK DOWN. THE SENSOR WAS REMOVED FROM THE PATIENT AND REPLACED A NEW ONE, BUT THE PROBLEM CONTINUED. THE MONITOR WAS CHANGED WITH A NEW ONE AND DID NOT GIVE ANY ISSUE. THERE WAS NO HARM CAUSE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510941 ↗MalfunctionSep 24, 2022High Readings; Insufficient Device Problem Information; High Readings; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE BIS INDEX VALUE STAYED IN HIGH 90S DURING INDUCTION DESPITE INCREASE IN ANAESTHETIC. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15480368 ↗
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 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
- BIS 186-0299-RFBCovidien LP · Index-generating electroencephalograph software4 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page