• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASTIFLEX GROUP NV
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNSET HEALTHCARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K173280  Neonatal ConchaSmart Breathing Circuits
VYAIRE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 338 338
2015 155 155
2016 212 212
2017 209 209
2018 102 102
2019 134 134
2020 123 123
2021 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 307 307
Leak/Splash 212 212
Insufficient Heating 158 158
Disconnection 109 109
Break 94 94
Temperature Problem 94 94
Device Operates Differently Than Expected 84 84
Gas Leak 60 60
Hole In Material 49 49
Moisture or Humidity Problem 39 39
Device Issue 34 34
Connection Problem 32 32
Failure of Device to Self-Test 31 31
Melted 29 29
Device Displays Incorrect Message 28 28
Loose or Intermittent Connection 24 24
Air Leak 23 23
Incorrect, Inadequate or Imprecise Resultor Readings 21 21
Detachment Of Device Component 17 17
Detachment of Device or Device Component 14 14
Therapeutic or Diagnostic Output Failure 13 13
Power Problem 13 13
Device Damaged Prior to Use 12 12
Material Puncture/Hole 12 12
Material Separation 12 12
Failure to Power Up 11 11
Fluid Leak 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Device Slipped 9 9
Cut In Material 9 9
Device Handling Problem 9 9
No Apparent Adverse Event 8 8
Overheating of Device 8 8
Use of Device Problem 7 7
Insufficient Information 6 6
Material Integrity Problem 6 6
Fitting Problem 6 6
Ambient Temperature Problem 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Pressure Problem 5 5
Split 5 5
Material Perforation 5 5
Material Split, Cut or Torn 4 4
Component Falling 4 4
Decrease in Pressure 4 4
Moisture Damage 3 3
Partial Blockage 3 3
Thermal Decomposition of Device 3 3
Circuit Failure 3 3
Device Inoperable 3 3
Device Fell 3 3
Torn Material 3 3
Sparking 3 3
Degraded 3 3
Physical Property Issue 3 3
Fracture 2 2
Mechanical Problem 2 2
Smoking 2 2
Failure to Deliver 2 2
Improper Flow or Infusion 2 2
Device Operational Issue 2 2
Material Protrusion/Extrusion 2 2
No Flow 2 2
Output Problem 2 2
Mechanics Altered 2 2
Unintended Movement 2 2
Improper or Incorrect Procedure or Method 2 2
Material Discolored 2 2
Increase in Pressure 2 2
Device Stops Intermittently 2 2
Fail-Safe Design Failure 1 1
Delivered as Unsterile Product 1 1
Device Alarm System 1 1
False Alarm 1 1
Defective Alarm 1 1
Failure To Adhere Or Bond 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dent in Material 1 1
Material Deformation 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Device-Device Incompatibility 1 1
Ventilation Problem in Device Environment 1 1
Data Problem 1 1
Component Misassembled 1 1
No Pressure 1 1
Positioning Problem 1 1
Material Torqued 1 1
Mechanical Jam 1 1
Misassembly by Users 1 1
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 462 462
No Patient Involvement 428 428
No Consequences Or Impact To Patient 291 291
No Clinical Signs, Symptoms or Conditions 102 102
Low Oxygen Saturation 39 39
No Information 30 30
No Code Available 8 8
Bradycardia 7 7
Tachycardia 5 5
Cardiac Arrest 3 3
Respiratory Distress 2 2
Patient Problem/Medical Problem 2 2
Full thickness (Third Degree) Burn 2 2
Injury 2 2
Increased Respiratory Rate 2 2
Insufficient Information 2 2
Hypoventilation 2 2
Burn(s) 2 2
Dyspnea 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Aspiration/Inhalation 1 1
Extubate 1 1
Fluid Discharge 1 1
Partial thickness (Second Degree) Burn 1 1
Exposure to Body Fluids 1 1
Needle Stick/Puncture 1 1
Alteration In Body Temperature 1 1
Scar Tissue 1 1
Therapeutic Response, Decreased 1 1
Death 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Sep-23-2014
2 Teleflex Medical I Jul-15-2019
-
-