Vital Signs Monitor; Advisor Model # BCI 9200

• • Terminated Z-1326-2009 FDA Unclassified (pre-2012) ·initiated 22 Dec 2008 ·on shared 510(k) K982279

  Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported.

• • Terminated Z-1089-2007 FDA Unclassified (pre-2012) ·initiated 5 Jun 2007 ·on shared 510(k) K982279

  Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.

• 21 recalls, same reason

  • Terminated Z-0229-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0239-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0221-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0235-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0223-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0230-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0231-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0225-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0227-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0232-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0228-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0224-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0238-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0234-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0237-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0220-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0233-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0222-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0240-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0236-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279
  • Terminated Z-0226-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K982279

  Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.

• 12 recalls, same reason

  • Terminated Z-0828-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0830-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0824-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0831-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0827-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0835-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0834-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0832-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0826-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0829-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0833-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279
  • Terminated Z-0825-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K982279

  Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.

• 5 recalls, same reason

  • Terminated Z-0533-05 FDA Unclassified (pre-2012) ·initiated 5 Jan 2005 ·on shared 510(k) K982279
  • Terminated Z-0534-05 FDA Unclassified (pre-2012) ·initiated 5 Jan 2005 ·on shared 510(k) K982279
  • Terminated Z-0531-05 FDA Unclassified (pre-2012) ·initiated 5 Jan 2005 ·on shared 510(k) K982279
  • Terminated Z-0535-05 FDA Unclassified (pre-2012) ·initiated 5 Jan 2005 ·on shared 510(k) K982279
  • Terminated Z-0532-05 FDA Unclassified (pre-2012) ·initiated 5 Jan 2005 ·on shared 510(k) K982279

  An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K982279 ↗

FDA Product Code

MHX

Models / Variants

Vital Signs Monitor

Advisor Model # Bci 9200

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Capnocheck II, Model 8400

  Class II

  FDA 510(k) K991086 Active Cleared 9 Jun 1999

• NEWOX2

  Class II

  FDA 510(k) K945754 Active Cleared 17 Jul 1995

• Autocorr Plus; 3404 Oximeter/ECG Monitor

  Class II

  FDA 510(k) K981939 Active Cleared 20 Aug 1998

• Pulse Oximeter

  Class II

  FDA 510(k) K941289 Active Cleared 22 Jun 1994

• 3301T Oxitemp

  Class II

  FDA 510(k) K946185 Active Cleared 17 Mar 1995

• BCI 3401 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K980714 Active Cleared 25 Mar 1998

See all devices from Bci Intl., Inc. →

• What is the Vital Signs Monitor Advisor Model # BCI 9200 used for?

  The Vital Signs Monitor Advisor Model # BCI 9200 is designed for continuous assessment of multiple vital signs including electrocardiogram (ECG), respiration, non-invasive blood pressure, pulse oximetry, invasive pressures, and temperature, providing comprehensive patient monitoring in hospital or clinical environments.

• How is the BCI 9200 supplied and is it reusable?

  The BCI 9200 is supplied as a reusable medical device with a portable, tabletop design. It requires appropriate sterilization and maintenance protocols according to manufacturer guidelines for continued safe and effective use in clinical settings.

• What regulatory status does the BCI 9200 have?

  The BCI 9200 has received FDA 510K clearance under the Cardiovascular Advisory Committee and is classified as a Class II device under regulation number 870.1025. It is not intended for MRI use and must be stored according to manufacturer guidelines.

• What parameters does the BCI 9200 monitor?

  The BCI 9200 provides real-time monitoring of electrocardiogram (ECG), respiration, non-invasive blood pressure, pulse oximetry, invasive pressures, and temperature, enabling comprehensive patient assessment in clinical settings with arrhythmia detection capabilities.