BIS 186-0106-PHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 90884521657515), received between Jan 9, 2023 and May 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K072286, K143506); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE LITERATURE, THE SENSOR CAUSED A REVERSIBLE SKIN LESION IN THE PATIENT UNDERGOING SURGERY. THE ELECTRODES WERE APPLIED, THE PATIENT WAS POSITIONED, AND PRESSURE AREAS WERE CAREFULLY PADDED AND USED FOR MONITORING DURING THIS UNEVENTFUL 2.5-HOUR PROCEDURE. AFTER REMOVING THE ELECTRODES, WELL-DEFINED, ERYTHEMATOUS MARKINGS WERE OBSERVED ON THE SKIN, CORRESPONDING TO THE ELECTRODE PLACEMENT SITES. THESE MARKINGS WERE CLASSIFIED AS NON-BLISTERING, NON-URTICARIAL, AND BLANCHING; THERE WERE NO OTHER SIGNS OF A SYSTEMATIC ALLERGIC REACTION. THE MARKS WERE NOT TYPICAL OF ALLERGIC CONTACT DERMATITIS BUT MORE LIKELY DUE TO AN IRRITANT AND THE PRESSURE EFFECT OF THE MONITOR. A FOLLOW-UP VISIT THREE WEEKS LATER REVEALED THE NEAR DISAPPEARANCE OF THE MARKS.

  Patient problems: Inflammation

  MAUDE report 19367215 ↗
• MalfunctionJan 9, 2023Defective Component; Patient Device Interaction Problem; Defective Component; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, SENSOR REDNESS MARKS ON PATIENT'S FOREHEAD. THREE DAYS AFTER THE SURGERY ON NOVEMBER 30, THE PATIENT TOOK A SHOWER ON DECEMBER 3, THE NURSE FOUND REDNESS AROUND THE SENSOR MARKS. THERE WAS NO REDNESS BEFORE THE SHOWER OR AFTER THE OPE.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 16122869 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072286, K143506. 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