Hp Carevue 9000 Clinical Information System, Model M2331A

• • Terminated Z-3111-2011 FDA Unclassified (pre-2012) ·initiated 8 Jul 2011

  Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended.

• • Terminated Z-2175-2011 FDA Unclassified (pre-2012) ·initiated 16 Mar 2011 ·on shared 510(k) K992636

  Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.

• • Terminated Z-0414-2011 FDA Unclassified (pre-2012) ·initiated 19 Oct 2010

  Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.

• • Terminated Z-0418-2010 FDA Unclassified (pre-2012) ·initiated 21 Oct 2009

  A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not be created.

• • Terminated Z-1654-2009 FDA Unclassified (pre-2012) ·initiated 5 May 2009

  Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.

• • Terminated Z-1436-2009 FDA Unclassified (pre-2012) ·initiated 5 May 2009

  Software: A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period

• 2 recalls, same reason

  • Terminated Z-1541-2008 FDA Unclassified (pre-2012) ·initiated 4 Mar 2008
  • Terminated Z-1540-2008 FDA Unclassified (pre-2012) ·initiated 4 Mar 2008

  Medications prescribed for one patient were printed on the record of another patient.

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

510(k) Number

K992636 ↗

FDA Product Code

DXJ

Device Class

Class II

Regulation

21 CFR Part 870.2450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Luer Lock Skirt

  Class II

  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

  Class II

  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

  Class II

  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

  Class II

  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

  Class I

  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

  Class II

  FDA 510(k) K781360 Active Cleared 7 Sep 1978

See all devices from Hewlett-Packard Co. →