BCI 3311Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517058253), received between Oct 25, 2021 and Aug 30, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 reports).

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

• MalfunctionAug 30, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CABLE DID NOT METER CORRECTLY ANYMORE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320515 ↗
• MalfunctionAug 30, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CONNECTION CORD IS MISSING A PIN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320494 ↗
• MalfunctionJul 26, 2022Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CABLES WERE FOUND TO HAVE SUSPECTED FRACTURES WITHIN THE PLUG/STRAIN RELIEF AT THE SENSOR END OF THE CABLE WHICH CAUSED INTERMITTENT SIGNAL TRANSMISSION WHEN GENTLY FLEXED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15104598 ↗
• MalfunctionOct 26, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A SMITHS MEDICAL DEVICE NEVER WORKED OUT OF THE PACKAGE. NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 12700747 ↗
• MalfunctionOct 25, 2021Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  IT WAS REPORTED THAT UPON TESTING BY PULMOLINK, BOTH CABLES WERE FOUND TO HAVE SUSPECTED FRACTURES WITHIN THE PLUG/STRAIN RELIEF AT THE SENSOR END OF THE CABLE WHICH CAUSED INTERMITTENT SIGNAL TRANSMISSION WHEN GENTLY FLEXED. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693838 ↗
• MalfunctionOct 25, 2021Failure to Power Up; Power Problem; Failure to Power Up; Power Problem

  IT WAS REPORTED THAT UPON TESTING BY PULMOLINK, BOTH CABLES WERE FOUND TO HAVE SUSPECTED FRACTURES WITHIN THE PLUG/STRAIN RELIEF AT THE SENSOR END OF THE CABLE WHICH CAUSED INTERMITTENT SIGNAL TRANSMISSION WHEN GENTLY FLEXED. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693644 ↗

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