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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Description Breathing system heater.
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION INC
  SUBSTANTIALLY EQUIVALENT 2
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
PLASTIFLEX GROUP NV
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K173280  Neonatal ConchaSmart Breathing Circuits

Device Problems
Crack 183
Insufficient Heating 127
Temperature Problem 92
Leak / Splash 58
Disconnection 55
Gas Leak 38
Device Issue 34
Connection Problem 25
Moisture or Humidity Problem 14
Breathing Circuit 13
Power Problem 12
Air Leak 12
Device Operates Differently Than Expected 10
Break 10
Y-Piece Connector 9
Device Handling Problem 9
Adverse Event Without Identified Device or Use Problem 9
Loose or Intermittent Connection 8
No Apparent Adverse Event 8
Cut In Material 8
Hole In Material 7
Failure to Power Up 6
Melted 6
Material Puncture / Hole 6
Insufficient Information 5
Material Perforation 5
Ambient Temperature Problem 5
Manufacturing, Packaging or Shipping Problem 5
Overheating of Device 4
Material Integrity Problem 4
Use of Device Problem 4
Split 3
Physical Property Issue 3
Detachment of Device or device Component 3
Increase in Pressure 2
Degraded 2
Device Operational Issue 2
Circuit Failure 2
Fracture 2
Material Separation 2
Fitting Problem 2
Mechanical Jam 1
Unexpected Shutdown 1
Fluid Leak 1
Connector 1
Detachment Of Device Component 1
Component Misassembled 1
Smoking 1
Failure to Deliver 1
Mechanical Problem 1
Torn Material 1
Tube 1
Temperature Probe 1
Intermittent loss of power 1
Material Deformation 1
Patient Device Interaction Problem 1
Changes In Ambient Temperature In Device Environment 1
Charred 1
Ventilation Problem in Device Environment 1
Device Inoperable 1
Mechanics Altered 1
Sparking 1
Material Discolored 1
Material Split, Cut or Torn 1
Device-Device Incompatibility 1
Human-Device Interface Problem 1
Device Emits Odor 1
Device Damaged Prior to Use 1
Defective Alarm 1
Latch 1
Thermal Decomposition of Device 1
Total Device Problems 844

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Sep-23-2014
2 Teleflex Medical I Jul-15-2019

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