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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 displays error message 91
Device operates differently than expected 68
Prompts will not clear 64
Leak 46
No Known Device Problem 33
Device Issue 9
Loss of power 6
Temperature issue 6
No display or display failure 5
Fluid leak 5
Insufficient cooling 3
Device stops intermittently 3
Insufficient heating 2
Difficult to insert 1
Electrical issue 1
Failure to power-up 1
Difficult to remove 1
Material separation 1
Power source issue 1
Electrical power problem 1
Therapeutic or diagnostic output failure 1
Total Device Problems 349

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 1 0 0 0 0 0 0 1 0 0
Class III 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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