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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device probe, thermodilution
Regulation Description Thermodilution probe.
Product CodeKRB
Regulation Number 870.1915
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ELECATH
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PULSION MEDICAL INC., USA
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 17
Leak 13
Deflation issue 10
Measurements, inaccurate 7
Disconnection 4
Incorrect measurement 3
Break 3
Inflation issue 2
Fracture 2
Material fragmentation 2
Material frayed 1
False reading from device non-compliance 1
Balloon rupture 1
Design/structure problem 1
Material rupture 1
Tears, rips, holes in device, device material 1
Component missing 1
Cut in material 1
Low readings 1
Detachment of device or device component 1
Foreign material present in device 1
Total Device Problems 74

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

Recalls
Manufacturer Recall Class Date Posted
1 Pulsion Medical Inc II Feb-17-2015

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