BCI 9004002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586036835), received between May 18, 2019 and Sep 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

1 other recall cover devices cleared under the same FDA submission (K970209); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE IS PRESENTING WITH AN ERROR E484. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397992 ↗
• MalfunctionAug 31, 2022Inaccurate Flow Rate; Mechanical Problem; Inaccurate Flow Rate; Mechanical Problem

  IT WAS REPORTED THAT NUMBERS WOULD DROP AND BE LOW THE DEVICE APPEARED TO ON ALL THE TIME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326934 ↗
• MalfunctionMay 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CAPNOGRAPHY MONITOR GAVE QUESTIONABLE CARBON DIOXIDE READINGS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8622395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970209. One submission often covers many models, so check the product and lot details in each record.

• Z-1014-2013 · Feb 6, 2013 · Terminated
  Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Pr