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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, thermal, infusion fluid
Product CodeLGZ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ARIZANT HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 2
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIEGLER GMBH
  SUBSTANTIALLY EQUIVALENT 1
HEI INC., ADVANCED MEDICAL DIVISION
  SUBSTANTIALLY EQUIVALENT 1
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PALADIN BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RAND S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
THE SMITHWORKS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 11
Detachment of device component 9
Leak 6
Air leak 4
Other (for use when an appropriate device code cannot be identified) 3
Foreign material 2
Smoking 2
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Wire(s), breakage of 1
Charging issue 1
Communication or transmission issue 1
Device unsafe to use in environment 1
Improper device output 1
Component(s), broken 1
Component(s), overheating of 1
Disconnection 1
Melted 1
Monitor display alarm, failure of 1
Overheating of device or device component 1
Total Device Problems 50

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 1 1 3 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Enginivity LLC II Sep-04-2009
2 Smiths Medical ASD, Inc. II Jul-09-2012
3 Smiths Medical ASD, Inc. II Jan-11-2012
4 Vital Signs Devices, a GE Healthcare Company II Jul-09-2012
5 Vital Signs Devices, a GE Healthcare Company II Aug-19-2011
6 Vital Signs Inc II Sep-03-2010

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