BCI 9004001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586036828), received between May 2, 2019 and Apr 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE THE NUMBER ON THE ETCO2 MACHINE WOULD NOT CONSISTENTLY READ CORRECTLY ON CUSTOMERS SLEEP SYSTEM. NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189579 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT THE CAPNOGRAPHY MONITOR CAPNOCHECK PLUS (9004) EXHIBITED PHYSICAL DAMAGE AND REQUIRED CALIBRATION. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575587 ↗

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