BIS 186-0195-PHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521130098), received between Jun 15, 2023 and Jun 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DOCTOR SEEMED TO BE SCRATCHED BY THE RESIN BURR OF THE CLIP PART OF THE DEVICE. THERE WAS A HALF AN INCH LINE/MARK/DISCOLORATION OF THE LEFT EXTERIOR FOREARM. THE SKIN APPEARED TO BE INTACT AND POSSIBLY BRUISED OR SUPERFICIALLY SCRATCHED.

  Patient problems: Bruise/Contusion

  MAUDE report 17139443 ↗

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