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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
  1.  K222822  VentStar Helix dual heated (N) Plus (MP02650), Ven ...
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
Material Puncture/Hole 15 15
Detachment of Device or Device Component 15 15
Loose or Intermittent Connection 14 14
Temperature Problem 14 14
Fluid/Blood Leak 13 13
Moisture or Humidity Problem 11 11
Use of Device Problem 10 10
Melted 9 9
Degraded 9 9
No Apparent Adverse Event 8 8
Material Separation 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Ambient Temperature Problem 6 6
Device Handling Problem 6 6
Material Perforation 5 5
Misconnection 4 4
Device Displays Incorrect Message 4 4
Material Deformation 4 4
Infusion or Flow Problem 4 4
Output Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Component Missing 3 3
Obstruction of Flow 3 3
Failure to Disconnect 3 3
Fitting Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Thermal Decomposition of Device 3 3
Fire 3 3
Device Fell 3 3
Misassembled During Installation 2 2
Corroded 2 2
Fracture 2 2
Air Leak 2 2
Device Alarm System 2 2
Material Discolored 2 2
Detachment Of Device Component 2 2
Overheating of Device 2 2
Misassembled 2 2
Device Issue 2 2
Overfill 2 2
Material Twisted/Bent 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Unintended Movement 1 1
Misassembly by Users 1 1
Power Problem 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Installation-Related Problem 1 1
Material Integrity Problem 1 1
Dent in Material 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Device Operates Differently Than Expected 1 1
Device-Device Incompatibility 1 1
Decrease in Pressure 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Device Inoperable 1 1
Insufficient Flow or Under Infusion 1 1
Product Quality Problem 1 1
Defective Component 1 1
Component Falling 1 1
Complete Blockage 1 1
Mechanical Problem 1 1
Material Disintegration 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 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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