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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
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 186
Device displays error message 147
Leak 99
Prompts will not clear 84
No Known Device Problem 49
Device Issue 28
No display or display failure 7
Temperature issue 7
Loss of power 6
Fluid leak 5
Insufficient cooling 4
Device stops intermittently 3
Failure to power-up 2
Insufficient heating 2
Difficult to insert 1
Loose or intermittent connection 1
Device alarm system issue 1
Electrical issue 1
Difficult to remove 1
Material separation 1
Therapeutic or diagnostic output failure 1
Power source issue 1
Electrical power problem 1
Excessive cooling 1
Total Device Problems 639

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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