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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system,network and communication,physiological monitors
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeMSX
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
Cardiopulmonary Corp.
  SUBSTANTIALLY EQUIVALENT 3
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 1
DATA CRITICAL
  1
  SUBSTANTIALLY EQUIVALENT 8
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 9
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 10
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 5
Not audible alarm 3
Unable to obtain readings 2
Smoking 1
Device inoperable 1
Device displays error message 1
Failure to fire 1
Computer software issue 1
No Known Device Problem 1
Device alarm system issue 1
Total Device Problems 17

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 2 2 1 0 1 2 0 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ascom US, INC. II May-10-2016
2 GE Healthcare II Apr-06-2009
3 GE Healthcare II Jun-24-2008
4 GE Healthcare II Nov-05-2008
5 GE Medical Systems, LLC II Sep-04-2009
6 Ge Healthcare, Llc II Aug-12-2010
7 Mindray DS USA, Inc. d.b.a. Mindray North America II Feb-11-2013
8 Mindray DS USA, Inc. d.b.a. Mindray North America II Jan-03-2013
9 Vidco, Inc. II Jan-04-2016
10 Visicu, Inc. II Dec-10-2015
11 Visicu, Inc. II Apr-27-2012

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