BCI WW1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 35019517062667), received between Apr 4, 2025 and Apr 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

43 other recalls cover devices cleared under the same FDA submission (K030407); 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.

Recalls naming this device

1. Feb 14, 2025Open, Classified

   Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

   Z-1404-2025 · Root cause: Process control · FDA record ↗

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 4, 2025Break; Break

  IT WAS REPORTED THAT THE PARTS KEPT BREAKING IN HALF. THERE WERE 2 PATIENTS' INVOLVEMENT, AND NO PATIENT WAS HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777671 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT THE AIRWAY ADAPTER OF THE DEVICE BROKE IN HALF WHICH IS KNOWN AS A RECALL. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE EVENT. THERE WAS ALSO NO MEDICAL INTERVENTION. HOWEVER, THE CARE TEAM NEEDED TO KEEP ADJUSTING AIRWAY ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777213 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030407. One submission often covers many models, so check the product and lot details in each record.

• Z-2379-2018 · Nov 29, 2017 · Terminated
  BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain func
• Z-1692-2015 · Mar 21, 2015 · Terminated
  Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
• Z-0918-2010 · Jan 15, 2010 · Terminated
  9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).
• Z-1326-2009 · Dec 22, 2008 · Terminated
  Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335
• Z-1089-2007 · Jun 5, 2007 · Terminated
  BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
• Z-0229-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0224-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0226-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0237-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0220-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0236-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0228-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0231-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0234-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main
• Z-0240-06 · Sep 1, 2005 · Terminated
  Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main

…and 28 more.