BIS 186-1001-RFBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521130173), received between Dec 30, 2020 and Sep 17, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Readings” (2 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 SENSORS WERE READING SPORADICALLY AND WOULD STOP WORKING, BUT AFTER POWER CYCLING THE DEVICE A COUPLE OF TIMES, THE SENSOR WOULD START READING CORRECTLY. FUNCTIONAL TESTING WAS CONDUCTED BY SWAPPING OUT SENSORS BUT THE SAME ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077424 ↗
• MalfunctionNov 8, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD LOW READINGS CAUSING LOW DOSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646304 ↗
• MalfunctionFeb 29, 2024Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, WHEN THE ELECTROMEDICAL TECHNICIAN WAS CHECKING THE UNIT, IT WAS NOT RINGING. HOWEVER, THE UNIT HAD VISUAL ALARMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809840 ↗
• MalfunctionJul 27, 2022Computer Software Problem; Noise, Audible; Computer Software Problem; Noise, Audible

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD SPEAKER ISSUE. WHEN THE DEVICE WAS POWERED ON, THERE WAS NO OTHER NOISE COMING OUT, BUT IT WAS GIVING STATIC SOUND/PUTTERING SOUND, NO ERROR CODES AND HAD NO ALARM. THE USER POWER CYCLED THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113599 ↗
• MalfunctionJun 1, 2022Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS SHOWING LOW READINGS. THE CUSTOMER USED MORE THAN ONE DEVICE ON THE PATIENT DURING A CASE AND THE REPORTED UNIT SHOWED A DIFFERENCE IN 20-50 POINTS FROM THE OTHER DEVICES ATTACHED TO THE PATIENT AT THE SAME TIME THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568305 ↗
• MalfunctionDec 30, 2020Image Display Error/Artifact; Temperature Problem; Image Display Error/Artifact; Temperature Problem

  ACCORDING TO THE REPORTER, WHILE PREPPING ON PATIENT, THE DEVICE DISPLAYED OVER CURRENT MESSAGE WHEREIN THE SENSOR PLUG WAS MELTED ON THE FIRST USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095551 ↗

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