BIS 186-0224-AMSRecalls & reported problems
Covidien LP · BISX4 Module,Software Version 1.15,For use with BIS Complete Monitors · Class 2
All models of BIS (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien LP BIS X4 module is electroencephalograph software used with BIS Complete Monitors. Reports mostly describe incorrect or discontinuous brain-wave index readings, sometimes alarms or a burned cable, with unclear patient impact. There are 41 adverse event reports naming this device's identifier, including 1 death and 1 injury. No recalls name this device. Reports fell from 10 in the previous 12 months to 3 in the latest 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
- 41
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521129559), received between Dec 5, 2018 and Aug 27, 2026 — classified as 1 death, 1 injury, 39 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (30 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement30
- Low Readings4
- Device Alarm System3
- Image Display Error/Artifact3
- Temperature Problem3
- Failure to Analyze Signal2
- Use of Device Problem2
- Communication or Transmission Problem1
Patient problems
- Insufficient Information34
- No Clinical Signs, Symptoms or Conditions5
- Death1
- Injury1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Incorrect Measurement
It was reported that the device was not measuring correctly. It was unknown if there was any patient involvement or complications as a result of the event.
Patient problems: Insufficient Information
MAUDE report 50479485 ↗MalfunctionJun 24, 2026Incorrect Measurement; Unable to Obtain Readings
IT WAS REPORTED THAT THE MODULE HAD WRONG VALUES AND READING VALUES DISCONTINUOUSLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 25615875 ↗MalfunctionNov 25, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE WAS REPORTED VALUES NOT MATCHING EXPECTED OR CLINICAL VALUES, AND THE DEVICE READINGS DID NOT ALIGN WITH THE PATIENT'S SEDATION STATUS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 23648543 ↗MalfunctionOct 20, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE EXPERIENCED A FAILURE AND PRODUCED INCORRECT DATA. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 23342400 ↗MalfunctionAug 8, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT INCORRECT VALUES WERE OBSERVED WITH THE DEVICE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 22754919 ↗MalfunctionJul 14, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE MEASURED INCORRECT VALUES. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 22495701 ↗MalfunctionMay 22, 2025Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement
IT WAS REPORTED THAT INCORRECT VALUES WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22069952 ↗MalfunctionMay 19, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THE CABLE WAS BURNED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 22043520 ↗MalfunctionApr 18, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING USE, THE UNIT STOPPED GIVING RELIABLE SIGNAL. THE INCORRECT READINGS WERE BASED ON COMPARING THE RESULT TO OTHER MULTIPARAMETER MONITOR VALUES. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21866662 ↗MalfunctionJan 9, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE DID NOT READ PROPERLY, OR DID NOT RECORD SUCCESSFULLY. THE CIRCUMSTANCES UNDER WHICH THE ISSUE WAS OBSERVED, AS WELL AS ANY PATIENT INVOLVEMENT OR COMPLICATIONS, WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21118471 ↗MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CABLE FAILED FROM TIME TO TIME, FALSIFYING THE MEASUREMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627360 ↗MalfunctionNov 7, 2024Image Display Error/Artifact; Incorrect Measurement; Image Display Error/Artifact; Incorrect Measurement
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD INCORRECT READINGS AND ERROR CODE ON ELECTRODE 2. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20626758 ↗MalfunctionNov 6, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT HAD INCORRECT READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 20625277 ↗MalfunctionAug 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD WRONG VALUE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19928628 ↗MalfunctionAug 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD WRONG VALUE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19928566 ↗MalfunctionAug 7, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT HAD WRONG VALUE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19927136 ↗MalfunctionAug 6, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT HAD WRONG VALUE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19917318 ↗MalfunctionApr 26, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT GAVE INCORRECT DATA. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19193307 ↗MalfunctionApr 15, 2024Device Alarm System; Image Display Error/Artifact; Communication or Transmission Problem; Device Alarm System; Image Display Error/Artifact; Communication or Transmission Problem
ACCORDING TO THE REPORTER, THE MONITOR WOULD NOT RECOGNIZE THAT IT WAS CONNECTED TO THE UNIT STRIP. IT WOULD NOT ALARM AND KEPT SAYING CONNECT LIST. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19104656 ↗MalfunctionApr 11, 2024Incorrect Measurement; Failure to Analyze Signal; Use of Device Problem; Incorrect Measurement; Failure to Analyze Signal; Use of Device Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD A MISSING AND INCORRECT PATIENT DATA. A FAULT IN PATIENT INTERFACE CABLE WAS ALSO REPORTED ASKING TO LOCK THE CABLE USING THE SENSOR SIMULATOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19093822 ↗MalfunctionApr 10, 2024Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT DID NOT READ PROPERLY AND HAD NO ALARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19082111 ↗MalfunctionFeb 23, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD UNRELIABLE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18771344 ↗MalfunctionFeb 23, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD UNRELIABLE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18771289 ↗MalfunctionFeb 20, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE DEVICE HAD UNRELIABLE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18741961 ↗MalfunctionFeb 12, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT HAD AN INCORRECT READING. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18692247 ↗
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 186-0195-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
- 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 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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