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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

MDR Year MDR Reports MDR Events
2015 155 155
2016 212 212
2017 209 209
2018 102 102
2019 134 134
2020 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 254 254
Insufficient Heating 119 119
Leak/Splash 115 115
Temperature Problem 90 90
Disconnection 86 86
Breathing Circuit 52 52
Gas Leak 48 48
Break 38 38
Device Issue 34 34
Moisture or Humidity Problem 33 33
Connection Problem 28 28
Loose or Intermittent Connection 24 24
Device Operates Differently Than Expected 20 20
Melted 20 20
Hole In Material 15 15
Air Leak 14 14
Detachment Of Device Component 14 14
Detachment of Device or Device Component 13 13
Incorrect, Inadequate or Imprecise Resultor Readings 12 12
Y-Piece Connector 12 12
Material Separation 10 10
Cut In Material 9 9
Device Handling Problem 9 9
Device Displays Incorrect Message 9 9
Connector 8 8
No Apparent Adverse Event 8 8
Tube 8 8
Probe 7 7
Material Puncture/Hole 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Power Up 6 6
Overheating of Device 5 5
Fluid Leak 5 5
Use of Device Problem 5 5
Material Perforation 5 5
Split 5 5
Insufficient Information 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Integrity Problem 5 5
Power Problem 5 5
Ambient Temperature Problem 5 5
Fitting Problem 5 5
Failure of Device to Self-Test 4 4
Wire 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Slipped 4 4
Degraded 3 3
Physical Property Issue 3 3
Material Split, Cut or Torn 3 3
Moisture Damage 3 3
Thermal Decomposition of Device 3 3
Circuit Failure 3 3
Pressure Problem 3 3
Device Subassembly 3 3
Temperature Probe 3 3
Device Fell 3 3
Partial Blockage 2 2
Mechanics Altered 2 2
Component Falling 2 2
Material Discolored 2 2
Device Damaged Prior to Use 2 2
Decrease in Pressure 2 2
Increase in Pressure 2 2
Device Inoperable 2 2
Device Operational Issue 2 2
Improper Flow or Infusion 2 2
Heater 2 2
Filter 2 2
Cap 2 2
Failure to Deliver 2 2
Fracture 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 1 1
Inaccurate Delivery 1 1
Smoking 1 1
Failure to Sense 1 1
Adapter (Adaptor) 1 1
Cylinder 1 1
Disassembly 1 1
Material Disintegration 1 1
Fire 1 1
No Audible Alarm 1 1
Changes In Ambient Temperature In Device Environment 1 1
Charred 1 1
Installation-Related Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Output Problem 1 1
Device Dislodged or Dislocated 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Incorrect Or Inadequate Test Results 1 1
Overfill 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Patient Device Interaction Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 301 301
No Patient Involvement 294 294
No Consequences Or Impact To Patient 265 265
Low Oxygen Saturation 31 31
No Information 11 11
Bradycardia 6 6
No Code Available 5 5
Cardiac Arrest 3 3
Tachycardia 3 3
Patient Problem/Medical Problem 2 2
Hypoventilation 2 2
Burn(s) 2 2
Fever 1 1
Extubate 1 1
Fluid Discharge 1 1
Full thickness (Third Degree) Burn 1 1
Needle Stick/Puncture 1 1
Increased Respiratory Rate 1 1
Hypoxia 1 1
Pulmonary Edema 1 1
Respiratory Distress 1 1
Exposure to Body Fluids 1 1

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