Bci Advisor Vital Signs Monitor (9200)

• • Terminated Z-1326-2009 FDA Unclassified (pre-2012) ·initiated 22 Dec 2008 ·on shared 510(k) K010770

  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

  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-0233-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0222-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0240-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0230-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0225-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0232-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0238-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0237-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0220-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0236-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0226-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0229-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0239-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0221-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0223-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0231-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0228-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0227-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0235-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0224-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770
  • Terminated Z-0234-06 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K010770

  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-0824-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0833-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0831-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0830-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0832-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0828-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0827-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0835-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0826-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0834-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0829-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770
  • Terminated Z-0825-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005 ·on shared 510(k) K010770

  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.

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

510(k) Number

K010770 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bci 3178 Pediatric Pulse Oximetry Sensor

  Class II

  FDA 510(k) K020739 Active Cleared 3 Jun 2002

• Bci 3180 Pulse Oximeter

  Class II

  FDA 510(k) K020350 Active Cleared 30 Apr 2002

• Irrigator, Body Cavity

  Class II

  FDA 510(k) K781918 Active Cleared 15 Feb 1979

• Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter

  Class II

  FDA 510(k) K031742 Active Cleared 18 Aug 2003

• 3420 Digit Pulse Oximeter, Model 3420

  Class II

  FDA 510(k) K013171 Active Cleared 3 Jan 2002

• Capnocheck Open recall

  Class II

  FDA 510(k) K941982 Active Cleared 17 Oct 1994

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