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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

Device Problems
Crack 178
Insufficient Heating 123
Temperature Problem 92
Leak / Splash 51
Device Issue 34
Disconnection 25
Connection Problem 23
Gas Leak 16
Moisture or Humidity Problem 13
Breathing Circuit 12
Power Problem 12
Air Leak 12
Device Operates Differently Than Expected 10
Break 10
Y-Piece Connector 8
Cut In Material 8
Device Handling Problem 8
Adverse Event Without Identified Device or Use Problem 8
Hole In Material 7
No Apparent Adverse Event 6
Loose or Intermittent Connection 6
Failure to Power Up 6
Melted 6
Material Puncture / Hole 5
Insufficient Information 5
Use of Device Problem 4
Material Integrity Problem 4
Overheating of Device 4
Material Perforation 4
Detachment of Device or device Component 3
Split 3
Physical Property Issue 3
Material Separation 2
Device Operational Issue 2
Increase in Pressure 2
Ambient Temperature Problem 2
Circuit Failure 2
Fracture 2
Changes In Ambient Temperature In Device Environment 1
Charred 1
Ventilation Problem in Device Environment 1
Device Inoperable 1
Degraded 1
Material Discolored 1
Mechanics Altered 1
Sparking 1
Device-Device Incompatibility 1
Human-Device Interface Problem 1
Manufacturing, Packaging or Shipping Problem 1
Device Emits Odor 1
Device Damaged Prior to Use 1
Defective Alarm 1
Latch 1
Thermal Decomposition of Device 1
Fitting Problem 1
Mechanical Jam 1
Connector 1
Detachment Of Device Component 1
Smoking 1
Failure to Deliver 1
Mechanical Problem 1
Torn Material 1
Temperature Probe 1
Intermittent loss of power 1
Patient Device Interaction Problem 1
Material Deformation 1
Total Device Problems 749

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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