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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
PLASTIFLEX GROUP NV
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 180
Insufficient Heating 111
Temperature Problem 90
Leak / Splash 57
Device Issue 34
Disconnection 31
Connection Problem 25
Gas Leak 22
Moisture or Humidity Problem 14
Breathing Circuit 12
Air Leak 12
Break 10
Y-Piece Connector 9
Cut In Material 8
Device Handling Problem 8
Device Operates Differently Than Expected 7
Loose or Intermittent Connection 7
No Apparent Adverse Event 7
Hole In Material 7
Adverse Event Without Identified Device or Use Problem 6
Melted 6
Material Puncture / Hole 6
Failure to Power Up 6
Use of Device Problem 4
Material Integrity Problem 4
Power Problem 4
Insufficient Information 4
Material Perforation 4
Ambient Temperature Problem 4
Overheating of Device 3
Detachment of Device or device Component 3
Physical Property Issue 3
Split 3
Material Separation 2
Increase in Pressure 2
Device Operational Issue 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
Mechanics Altered 1
Material Split, Cut or Torn 1
Degraded 1
Material Discolored 1
Device-Device Incompatibility 1
Human-Device Interface Problem 1
Manufacturing, Packaging or Shipping Problem 1
Device Damaged Prior to Use 1
Latch 1
Thermal Decomposition of Device 1
Fitting Problem 1
Mechanical Jam 1
Unexpected Shutdown 1
Fluid Leak 1
Connector 1
Detachment Of Device Component 1
Component Misassembled 1
Torn Material 1
Smoking 1
Failure to Deliver 1
Mechanical Problem 1
Temperature Probe 1
Intermittent loss of power 1
Patient Device Interaction Problem 1
Material Deformation 1
Total Device Problems 750

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical I Jul-15-2019

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