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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
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION INC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EXCELERON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  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
VYAIRE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 338 338
2015 155 155
2016 212 212
2017 209 209
2018 103 103
2019 134 134
2020 123 123
2021 124 124
2022 152 152
2023 124 124
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 418 418
Crack 358 358
Gas/Air Leak 177 177
Insufficient Heating 159 159
Break 133 133
Disconnection 114 114
Temperature Problem 94 94
Device Operates Differently Than Expected 84 84
Failure of Device to Self-Test 51 51
Hole In Material 49 49
Connection Problem 44 44
Therapeutic or Diagnostic Output Failure 42 42
Moisture or Humidity Problem 41 41
Material Split, Cut or Torn 40 40
Device Issue 34 34
Melted 31 31
Loose or Intermittent Connection 31 31
Device Displays Incorrect Message 28 28
Air Leak 23 23
Fluid/Blood Leak 22 22
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Detachment of Device or Device Component 17 17
Detachment Of Device Component 17 17
Material Puncture/Hole 15 15
Degraded 13 13
Power Problem 13 13
Device Damaged Prior to Use 13 13
Material Separation 12 12
Use of Device Problem 11 11
Failure to Power Up 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Device Slipped 10 10
Device Handling Problem 9 9
Cut In Material 9 9
Overheating of Device 8 8
No Apparent Adverse Event 8 8
Insufficient Information 7 7
Material Deformation 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Integrity Problem 6 6
Material Perforation 6 6
Ambient Temperature Problem 6 6
Mechanical Problem 6 6
Fitting Problem 6 6
Pressure Problem 6 6
Split 5 5
Decrease in Pressure 5 5
Component Missing 5 5
Infusion or Flow Problem 4 4
Misconnection 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 509 509
No Known Impact Or Consequence To Patient 462 462
No Patient Involvement 428 428
No Consequences Or Impact To Patient 291 291
Low Oxygen Saturation 53 53
No Information 30 30
No Code Available 8 8
Bradycardia 7 7
Insufficient Information 7 7
Tachycardia 6 6
Aspiration/Inhalation 4 4
Hypoxia 3 3
Increased Respiratory Rate 3 3
Cardiac Arrest 3 3
Burning Sensation 3 3
Full thickness (Third Degree) Burn 2 2
Headache 2 2
Injury 2 2
Burn(s) 2 2
Dizziness 2 2
Respiratory Distress 2 2
Hypoventilation 2 2
Patient Problem/Medical Problem 2 2
Fever 1 1
Needle Stick/Puncture 1 1
Alteration In Body Temperature 1 1
Exposure to Body Fluids 1 1
Dyspnea 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Respiratory Arrest 1 1
Fluid Discharge 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Death 1 1
Therapeutic Response, Decreased 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Unspecified Infection 1 1
Extubate 1 1
Irritability 1 1
Unspecified Vascular Problem 1 1
High Blood Pressure/ Hypertension 1 1
Respiratory Failure 1 1
Increased Peak Expiratory Flow rate 1 1

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