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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, hypothermia, intravenous, cooling
Regulation Description Thermal regulating system.
Product CodeNCX
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ALSIUS CORP.
  SE - WITH LIMITATIONS 4
  SUBSTANTIALLY EQUIVALENT 5
INNERCOOL THERAPIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIANT INNOVATION, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 128
Device displays error message 118
Prompts will not clear 76
Leak 71
No Known Device Problem 45
Device Issue 16
Loss of power 6
No display or display failure 6
Temperature issue 6
Fluid leak 5
Device stops intermittently 3
Insufficient cooling 3
Failure to power-up 2
Insufficient heating 2
Difficult to insert 1
Electrical power problem 1
Difficult to remove 1
Material separation 1
Device alarm system issue 1
Electrical issue 1
Therapeutic or diagnostic output failure 1
Power source issue 1
Total Device Problems 495

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alsius Corporation II Feb-15-2007
2 Philips Healthcare II Jan-27-2014

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