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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
Product CodeBZE
Regulation Number 868.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201418  Sunset Heated CPAP Tube
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 103 103
2019 134 134
2020 123 123
2021 124 124
2022 152 152
2023 123 123
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 262 262
Gas/Air Leak 150 150
Crack 96 96
Insufficient Heating 72 72
Disconnection 63 63
Break 52 52
Therapeutic or Diagnostic Output Failure 42 42
Material Split, Cut or Torn 39 39
Failure of Device to Self-Test 29 29
Connection Problem 24 24
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Detachment of Device or Device Component 15 15
Material Puncture/Hole 15 15
Temperature Problem 14 14
Loose or Intermittent Connection 14 14
Fluid/Blood Leak 13 13
Moisture or Humidity Problem 11 11
Use of Device Problem 10 10
Degraded 9 9
Melted 9 9
No Apparent Adverse Event 8 8
Material Separation 7 7
Device Handling Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Ambient Temperature Problem 6 6
Material Perforation 5 5
Output Problem 4 4
Material Deformation 4 4
Misconnection 4 4
Infusion or Flow Problem 4 4
Device Displays Incorrect Message 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Obstruction of Flow 3 3
Component Missing 3 3
Fire 3 3
Device Fell 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
Failure to Disconnect 3 3
Thermal Decomposition of Device 3 3
Device Alarm System 2 2
Overheating of Device 2 2
Insufficient Information 2 2
Pressure Problem 2 2
Detachment Of Device Component 2 2
Air Leak 2 2
Protective Measures Problem 2 2
Device Issue 2 2
Material Discolored 2 2
Corroded 2 2
Fracture 2 2
Material Twisted/Bent 2 2
Misassembled During Installation 2 2
Overfill 2 2
Appropriate Term/Code Not Available 2 2
Misassembled 2 2
Contamination /Decontamination Problem 1 1
Component Misassembled 1 1
Deformation Due to Compressive Stress 1 1
Sparking 1 1
Material Disintegration 1 1
Human-Device Interface Problem 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1
Product Quality Problem 1 1
Power Problem 1 1
Defective Component 1 1
Device Inoperable 1 1
Mechanical Jam 1 1
Complete Blockage 1 1
Unexpected Shutdown 1 1
Misassembly by Users 1 1
Installation-Related Problem 1 1
Patient Device Interaction Problem 1 1
Intermittent Loss of Power 1 1
Device-Device Incompatibility 1 1
Unintended Movement 1 1
Inadequacy of Device Shape and/or Size 1 1
Decrease in Pressure 1 1
Dent in Material 1 1
Separation Problem 1 1
Noise, Audible 1 1
Device Slipped 1 1
Improper Flow or Infusion 1 1
Mechanical Problem 1 1
Component Falling 1 1
Insufficient Flow or Under Infusion 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 422 422
No Patient Involvement 146 146
No Known Impact Or Consequence To Patient 96 96
No Consequences Or Impact To Patient 77 77
Low Oxygen Saturation 28 28
Insufficient Information 6 6
Bradycardia 4 4
Hypoxia 3 3
Hypoventilation 2 2
Burn(s) 2 2
Burning Sensation 2 2
Cardiac Arrest 1 1
Death 1 1
Dyspnea 1 1
Aspiration/Inhalation 1 1
Laceration(s) 1 1
Pneumothorax 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Irritability 1 1
Increased Peak Expiratory Flow rate 1 1
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Unspecified Respiratory Problem 1 1

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