Quantitative Sentinel System

• • Terminated Z-0112-2009 FDA Unclassified (pre-2012) ·initiated 25 Sep 2008

  On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.

• • Terminated Z-0456-2009 FDA Unclassified (pre-2012) ·initiated 25 Sep 2008

  Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.

• • Terminated Z-2037-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008

  Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.

510(k) Number

K993008 ↗

FDA Product Code

HGM

Device Class

Class II

Regulation

21 CFR Part 884.2740

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option

  Not classified

  FDA 510(k) K974199 Active Cleared 6 Feb 1998

• Dash 1000 Patient Monitor

  Class II

  FDA 510(k) K970545 Active Cleared 8 May 1997

• Apex Oximeter

  Class II

  FDA 510(k) K980299 Active Cleared 24 Apr 1998

• Cardiosmart St

  Not classified

  FDA 510(k) K973403 Active Cleared 12 Mar 1998

• Muse Cardiovascular Information System

  Not classified

  FDA 510(k) K980495 Active Cleared 7 May 1998

• Rac 2A Module Housing

  Class II

  FDA 510(k) K973984 Active Cleared 16 Jan 1998

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