BIS 186-0200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521134331), received between Mar 1, 2021 and Feb 4, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PEDIATRIC PATIENT IN THE INTENSIVE CARE UNIT HAD PRESSURE ULCERS FROM THE SENSOR. THE PATIENT, WHO WAS PARALYZED, HAD THE SENSOR APPLIED TO THE FOREHEAD AFTER THE AREA WAS CLEANED WITH AN ALCOHOL WIPE. THE SENSOR WAS USED FROM 8 PM ON (B)(6), 2025, UNTIL 10 AM ON (B)(6) 2025. UPON REMOVAL, RED SORES AND SCABS WERE OBSERVED ON THE PATIENT'S FOREHEAD, INDICATING THAT THE SENSOR HAD BROKEN THE SKIN AND CAUSED A PRESSURE ULCER. THE PATIENT DID NOT HAVE ANY PREEXISTING SKIN CONDITIONS OR KNOWN ALLERGIES, AND THE SENSOR WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE AND PROTOCOL. THE SKIN INTEGRITY ISSUE PERSISTED FOR THREE WEEKS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21309187 ↗
• MalfunctionJan 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, A CHILD EXPERIENCED WOUNDS AND THREE BURNS ON THE FOREHEAD AFTER USING SENSOR. THE PATCH HAS BEEN CHANGED SEVERAL TIMES.

  Patient problems: Burn(s)

  MAUDE report 21272709 ↗
• MalfunctionDec 12, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER DURING USE, THE BIS VALUE WAS DISPLAYED AS 0 AT THE STAGE WHEN IT WAS WAS NOT UNDER ANESTHESIA. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20912975 ↗
• MalfunctionMay 5, 2023Erratic or Intermittent Display; Defective Component; Patient Device Interaction Problem; Erratic or Intermittent Display; Defective Component; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD ERRATIC READING. IT WAS NOT WORKING EFFECTIVELY FOR THE FULL LENGTH OF THE CASE REQUIRING SIGNIFICANT MANIPULATION TO WORK. THE USER PUT ADDITIONAL WATER BASED GEL ON EACH SENSOR, APPLIED IT TO FOREHEAD, HOLD IT IN PLACE WITH ADDITIONAL WIDE AREA ADHESIVE TAPE, APPLIED GENTLE PRESSURE TO EXPEL ANY AIR AT THE INTERFACE AND WRAPPING THE STEM OF THE SENSOR IN GAUZE, TO ALLOW THE MONITOR TO WORK EFFECTIVELY AND STICK EASILY. THE PATIENT RECOVERED DESPITE THE PEDIATRIC SENSORS LEAVING MARKS ON THE SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation

  MAUDE report 16876206 ↗
• MalfunctionMar 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE DEVICE WAS UTILIZED DURING A LIVER TRANSPLANT IN A PATIENT WITH HYPERBILIRUBINEMIA. THE SURGERY TOOK 10 HOURS AND 30 MINUTES OF DURATION AND AFTER THE END OF SURGERY AND DEVICE DISCARDED, THE MEDICAL TEAM SAW THE SKIN INJURIES WHERE DEVICE WAS PLACED. THE SKIN INJURY INCLUDED BLISTERS ON THE SKIN IN A CIRCLE FORMAT THAT WAS SIMILAR TO THE INSIDE OF THE DEVICE'S ELECTRODES. AFTER A WEEK THE PATIENT DOES NOT HAVE ANY PROBLEMS IN THE LOCATION, THE BLISTERS ON THE SKIN DISAPPEARED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11395290 ↗