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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, pressure, catheter tip
Regulation Description Catheter tip pressure transducer.
Product CodeDXO
Regulation Number 870.2870
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 7
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 81
Incorrect or inadequate result 36
Incorrect measurement 28
Unsealed device packaging 25
Break 17
Measurements, inaccurate 15
Particulates 15
Foreign material present in device 12
No Known Device Problem 12
Detachment of device or device component 10
Device handling issue 9
No code available 6
Tear, rip or hole in device packaging 5
Contamination during use 5
Leak 4
Fracture 3
Incorrect display 2
Entrapment of device or device component 2
Component(s), broken 2
Device alarm system issue 2
Misassembled 2
Increase in pressure 2
Difficult to remove 2
Incorrect or inadequate test results 2
High Readings 2
No Information 2
Device disinfection or sterilization issue 1
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Device packaging compromised 1
Physical resistance 1
Defective item 1
Delamination 1
Failure to sense 1
Sticking 1
Device inoperable 1
Device damaged prior to use 1
Defective component 1
Failure to reset 1
Difficult to position 1
Air leak 1
Crack 1
Disconnection 1
Fire 1
Fluid leak 1
Difficult to flush 1
Foreign material 1
Material fragmentation 1
Hole in material 1
Excess flow or overinfusion 1
Kinked 1
Total Device Problems 328

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 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Edward Lifesciences, Llc II Sep-16-2015
2 Edwards Lifesciences, LLC II Dec-17-2015

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