BCI 9004003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586036415), received between Oct 30, 2021 and Sep 6, 2022 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THERE WAS AN ERROR OF OCCLUSION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361363 ↗
• MalfunctionOct 30, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT A SMITHS MEDICAL DEVICE FAILED DURING CALIBRATION. THE PUMP SEEMS TO BE CLOGGED OR WEAK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725066 ↗

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