BIS 186-1046Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10884521129511), received between Nov 16, 2017 and Sep 28, 2026 — classified as 2 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (43 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Analyze Signal

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50926550 ↗
• MalfunctionAug 25, 2026Incorrect Measurement

  It was reported that incorrect readings were observed with the product. It was unknown if there was any patient involvement or complications as a result of the event.

  Patient problems: Insufficient Information

  MAUDE report 50438997 ↗
• MalfunctionAug 5, 2026Image Display Error/Artifact; Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50140727 ↗
• MalfunctionMay 12, 2026Temperature Problem

  IT WAS REPORTED THAT DURING USE, THE MONITOR WAS OPERATING NORMALLY, BUT AN IGNITION OCCURRED FROM THE POWER OUTLET AND DID NOT TURN BACK ON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155899 ↗
• MalfunctionMay 4, 2026High Readings

  IT WAS REPORTED THAT DURING USE, THE DEVICE HAD AN INTERFERENCE AND ABNORMALLY HIGH READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068322 ↗
• MalfunctionApr 9, 2026Insufficient Heating; Contamination /Decontamination Problem; Temperature Problem

  IT WAS REPORTED THAT THE MONITOR SMELLED STRONGLY OF DEFECTIVE ELECTRONICS AND IT BECAME WARM. THE POWER CONNECTOR AND THE MAINS SOCKET ON THE MONITOR SHOWED RESIDUES OF LIQUID OR OILY SUBSTANCES. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24831939 ↗
• MalfunctionMar 12, 2026Incorrect Measurement

  IT WAS REPORTED THAT PRIOR TO USE, DURING PRE-OPERATIVE PREPARATION, THE MONITOR EXPERIENCED A BREAKDOWN WITH INTERMITTENT READING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24585428 ↗
• MalfunctionMar 12, 2026Device Alarm System

  IT WAS REPORTED THAT THE MONITOR HAD AN UNTIMELY ALARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24578760 ↗
• MalfunctionFeb 19, 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. THERE WAS NO PATIENT INJURY.

  Patient problems: Awareness During Anesthesia

  MAUDE report 24390659 ↗
• MalfunctionJan 30, 2026Incorrect Measurement

  IT WAS REPORTED THAT MEASURING WAS NOT ACCURATE 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 24228055 ↗
• MalfunctionJan 29, 2026Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT THE MONITOR DISPLAYED HARDWARE ERROR MESSAGE 2902 ON DEVICE START-UP DURING PRE-OPERATIVE PREPARATION FOR USE. THE MONITOR DID NOT ALARM WHEN THE ERROR OCCURRED. TROUBLESHOOTING STEPS INCLUDED REBOOTING THE MONITOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218776 ↗
• MalfunctionJan 26, 2026Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT THE UNIT DISPLAYED A HARDWARE TIMER ERROR (ERROR 2902) AND GAVE NO AUDIBLE ALARM WHEN THE MALFUNCTION OCCURRED. THE ERROR MESSAGE WAS CONFIRMED AND ISOLATED TO THE MONITOR, AND TROUBLESHOOTING INCLUDED SWITCHING MODULES. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24177041 ↗
• MalfunctionDec 11, 2025Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement

  IT WAS REPORTED THAT DURING TESTING AND DEMO, THE MONITOR DID NOT MEASURE CORRECTLY. THERE WERE NO ERRORS MESSAGES, AUDIO AND VISUAL ALARMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785717 ↗
• MalfunctionNov 26, 2025Incorrect Measurement; Failure to Power Up; Device Damaged Prior to Use; Incorrect Measurement; Failure to Power Up; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING USE, A DEVICE HAD INACCURATE DATA AND NOT WORKING WHEN ATTACHED TO A PATIENT, THE SCREEN KEPT TURNING OFF, AND THERE WAS A CRACK IN THE FRONT CASE. THE READINGS BECAME BETTER WHEN THE CABLE WAS SWAPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23656116 ↗
• MalfunctionNov 14, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT WAS PROVIDING INCORRECT READINGS FOLLOWING POST-OPERATIVE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552928 ↗
• InjuryNov 3, 2025Display or Visual Feedback Problem; Image Display Error/Artifact; Use of Device Problem; Display or Visual Feedback Problem; Image Display Error/Artifact; Use of Device Problem

  IT WAS REPORTED THAT THE SCREEN DID NOT REACT TO TOUCH AND AN UNRECOVERABLE ERROR OCCURRED DURING PROCEDURE. THE PATIENT REGAINED CONSCIOUSNESS DURING SURGERY DESPITE BEING UNDER ANESTHESIA.

  Patient problems: Awareness During Anesthesia

  MAUDE report 23460489 ↗
• MalfunctionNov 3, 2025Incorrect Measurement; Use of Device Problem; Incorrect Measurement; Use of Device Problem

  IT WAS REPORTED THAT THE MONITOR DISPLAYED INCONSISTENT READINGS PRIOR TO USE. ADDITIONALLY, WHEN A STIMULATOR TEST SENSOR KEY WAS USED, A SENSOR READING COULD NOT BE OBTAINED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459394 ↗
• MalfunctionSep 18, 2025Incorrect Measurement; Communication or Transmission Problem; Incorrect Measurement; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE OF THE DEVICE, THE SENSOR WAS SPORADICALLY READING AND THEN STOPPED WORKING. SENSORS WERE SWAPPED WITH KNOWN WORKING SENSORS TO ISOLATE THE ISSUE, BUT THE SAME PROBLEM PERSISTED. POWER CYCLING THE DEVICE A COUPLE OF TIMES ALLOWED THE SENSOR TO START READING CORRECTLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083474 ↗
• MalfunctionSep 17, 2025Incorrect Measurement; Communication or Transmission Problem; Incorrect Measurement; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE OF THE DEVICE, THE SENSOR WAS READING SPORADICALLY, WOULD STOP WORKING, AND ONLY STARTED READING CORRECTLY AFTER POWER CYCLING THE DEVICE MULTIPLE TIMES. THE DEVICE WAS UNABLE TO RECOGNIZE THE SENSOR AT TIMES. KNOWN WORKING SENSORS WERE SWAPPED IN, BUT THE SAME ISSUES PERSISTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077433 ↗
• 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 23027882 ↗
• MalfunctionAug 29, 2025Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  IT WAS REPORTED THAT THE UNIT DID NOT TURN ON. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE POWER SUPPLY SMELLED BURNED.

  Patient problems: Insufficient Information

  MAUDE report 22921443 ↗
• MalfunctionAug 29, 2025Display or Visual Feedback Problem; Incorrect Measurement; Display or Visual Feedback Problem; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT¿S SCREEN WENT BLACK AND THEN SHOWED INCORRECT READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921417 ↗
• MalfunctionAug 26, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MONITOR INITIALLY DISPLAYED READINGS OF 46-47, THEN INCREASED TO 61 BEFORE DROPPING BACK TO PREVIOUS LEVELS WHILE THE PATIENT REMAINED CONSCIOUS AND RESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894458 ↗
• MalfunctionAug 5, 2025Device Alarm System; Failure to Run on Battery; Device Alarm System; Failure to Run on Battery

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, A BATTERY FAILURE WAS OBSERVED. NO AUDIBLE OR VISIBLE ALARM WAS PRESENTED FOR THE FAILURE.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719031 ↗
• MalfunctionJul 30, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MONITOR EXHIBITED 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 22668992 ↗

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, Classified
  Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319