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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, oxygen, portable
Regulation Description Portable oxygen generator.
Product CodeCAW
Regulation Number 868.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 3167 3167
2017 107 107
2018 116 116
2019 120 120
2020 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 2128 2128
Power Switch 1119 1119
No Audible Alarm 412 412
Electrical /Electronic Property Problem 231 231
Circuit Failure 164 164
Fire 152 152
Device Operates Differently Than Expected 150 150
Break 147 147
Unit 146 146
Adverse Event Without Identified Device or Use Problem 111 111
Loss of Power 106 106
Electrical Shorting 105 105
Switch, Push Button 103 103
Defective Alarm 102 102
Defective Device 89 89
Device Displays Incorrect Message 87 87
Device Inoperable 85 85
Display 72 72
Thermal Decomposition of Device 40 40
Device Operational Issue 37 37
Melted 36 36
Noise, Audible 31 31
Defective Component 31 31
Overheating of Device 30 30
Improper or Incorrect Procedure or Method 29 29
Insufficient Information 27 27
Failure to Power Up 26 26
Leak/Splash 25 25
Explosion 23 23
Out-Of-Box Failure 23 23
No Display/Image 22 22
Switches 21 21
Use of Device Problem 20 20
Smoking 19 19
Valve(s) 19 19
Device Emits Odor 18 18
Alarm 17 17
Screen 17 17
Mechanical Problem 14 14
Concentrator 14 14
Infusion or Flow Problem 14 14
Unexpected Shutdown 13 13
Battery Problem 13 13
Failure to Deliver 12 12
Sparking 9 9
No Flow 9 9
Light Interference 9 9
Electronic Property Issue 9 9
Disconnection 9 9
Power Problem 9 9
Temperature Problem 8 8
No Apparent Adverse Event 8 8
Component Missing 7 7
Device Contamination with Chemical or Other Material 7 7
Device Stops Intermittently 6 6
Detachment Of Device Component 6 6
Power Cord 6 6
Environmental Particulates 6 6
Crack 6 6
Gas Output Problem 6 6
No Device Output 6 6
Cord 6 6
PC (Printed Circuit) Board 6 6
Compressor 6 6
Fluid Leak 5 5
Function Indicator Light 5 5
Contamination 5 5
Sticking 5 5
Charging Problem 5 5
Cannula 5 5
Improper Device Output 4 4
Insufficient Flow or Under Infusion 4 4
Loose or Intermittent Connection 4 4
Material Discolored 4 4
Battery 4 4
Alarm, Audible 4 4
Wire 4 4
Therapeutic or Diagnostic Output Failure 4 4
Failure to Shut Off 4 4
Screw 4 4
Tube 4 4
Heat Exchanger 3 3
Panel 3 3
Failure to Charge 3 3
Environmental Compatibility Problem 3 3
Computer Operating System Problem 3 3
Gas Leak 3 3
Improper Flow or Infusion 3 3
Inadequate Lighting 3 3
Output Problem 3 3
Appropriate Term/Code Not Available 3 3
Material Frayed 3 3
Device Damaged Prior to Use 3 3
Manufacturing, Packaging or Shipping Problem 3 3
No Pressure 3 3
Device Subassembly 3 3
Material Integrity Problem 2 2
Optical Problem 2 2
Output below Specifications 2 2
Material Deformation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2980 2980
No Information 169 169
No Consequences Or Impact To Patient 143 143
Death 102 102
Burn(s) 59 59
No Patient Involvement 53 53
Low Oxygen Saturation 34 34
Patient Problem/Medical Problem 25 25
No Code Available 23 23
Partial thickness (Second Degree) Burn 19 19
Respiratory Distress 15 15
Full thickness (Third Degree) Burn 11 11
Dyspnea 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Superficial (First Degree) Burn 8 8
Injury 8 8
Hypoxia 7 7
Burn, Thermal 6 6
Pain 4 4
Loss of consciousness 4 4
Fainting 3 3
Pneumonia 3 3
Headache 3 3
Dizziness 3 3
Complaint, Ill-Defined 3 3
Reaction 3 3
Unspecified Infection 3 3
Bruise/Contusion 2 2
Burning Sensation 2 2
Increased Respiratory Rate 2 2
Blister 1 1
Skin Inflammation/ Irritation 1 1
Red Eye(s) 1 1
Disability 1 1
Ventilator Dependent 1 1
Sore Throat 1 1
Respiratory Tract Infection 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
Test Result 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Adult Respiratory Distress Syndrome 1 1
Asthma 1 1
Asphyxia 1 1
Hair Loss 1 1
Head Injury 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Nausea 1 1
Seizures 1 1
Vomiting 1 1
Weakness 1 1
Fall 1 1
Hearing Loss 1 1
Inflammation 1 1
Neuropathy 1 1
Sprain 1 1
Concussion 1 1
Pulmonary Emphysema 1 1
Congestive Heart Failure 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Ischemic Heart Disease 1 1
Shock, Traumatic 1 1
Malaise 1 1
Collapse 1 1
Coma 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II Jan-13-2020
2 Caire, Inc. II Oct-30-2019
3 Inovo, Inc II Jan-24-2018
4 Inovo, Inc II Dec-14-2016
5 Invacare Corporation II Dec-01-2020
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