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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 177
Insufficient Heating 121
Temperature Problem 92
Leak / Splash 51
Device Issue 34
Connection Problem 23
Disconnection 20
Gas Leak 14
Moisture or Humidity Problem 13
Power Problem 12
Air Leak 12
Breathing Circuit 11
Break 10
Device Operates Differently Than Expected 10
Cut In Material 8
Adverse Event Without Identified Device or Use Problem 8
Y-Piece Connector 8
Hole In Material 7
Device Handling Problem 7
No Apparent Adverse Event 6
Failure to Power Up 6
Loose or Intermittent Connection 6
Melted 5
Insufficient Information 5
Material Integrity Problem 4
Overheating of Device 4
Material Puncture / Hole 4
Use of Device Problem 4
Material Perforation 4
Physical Property Issue 3
Split 3
Detachment of Device or device Component 3
Device Operational Issue 2
Ambient Temperature Problem 2
Material Separation 2
Increase in Pressure 2
Fracture 2
Circuit Failure 2
Detachment Of Device Component 1
Degraded 1
Material Discolored 1
Thermal Decomposition of Device 1
Charred 1
Connector 1
Defective Alarm 1
Changes In Ambient Temperature In Device Environment 1
Latch 1
Device Emits Odor 1
Mechanical Problem 1
Smoking 1
Device Inoperable 1
Device Damaged Prior to Use 1
Failure to Deliver 1
Fitting Problem 1
Torn Material 1
Ventilation Problem in Device Environment 1
Temperature Probe 1
Patient Device Interaction Problem 1
Intermittent loss of power 1
Device-Device Incompatibility 1
Sparking 1
Mechanical Jam 1
Mechanics Altered 1
Human-Device Interface Problem 1
Manufacturing, Packaging or Shipping Problem 1
Material Deformation 1
Total Device Problems 735

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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