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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, monitoring, perinatal
Regulation Description Perinatal monitoring system and accessories.
Product CodeHGM
Regulation Number 884.2740
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSTRIP TECHNOLOGIES, LP
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 3
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 8
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 32
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 11
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 3
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 7
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METRIX CO.
  SUBSTANTIALLY EQUIVALENT 1
NICOLET BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORANGE INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to analyze rhythm 14
Defective item 10
Device operates differently than expected 5
No Known Device Problem 3
No Information 3
Out-of-box failure 2
Device alarm system issue 2
Not audible alarm 1
False device output 1
False reading from device non-compliance 1
Interference with monitoring device 1
Loose or intermittent connection 1
Device displays error message 1
Incorrect interpretation of rhythm 1
Total Device Problems 46

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 4 2 0 0 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Datex Ohmeda, Inc. dba GE Healthcare II Aug-26-2008
2 GE Healthcare Integrated IT Solutions II Dec-03-2008
3 GE Healthcare Integrated IT Solutions II Oct-15-2008
4 GE Healthcare Integrated IT Solutions II Jul-30-2008
5 GE Healthcare It II Nov-18-2013
6 Philips Healthcare Inc. II Dec-17-2009
7 Philips Healthcare Inc. II Jun-26-2009
8 Philips Medical Systems, Inc. II Oct-21-2014

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