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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device generator, oxygen, portable
Regulation Description Portable oxygen generator.
Product CodeCAW
Regulation Number 868.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Alarm System 185
Adverse Event Without Identified Device or Use Problem 108
Fire 86
Break 56
Device Operates Differently Than Expected 52
Loss of Power 42
Display 42
Device Operational Issue 38
Thermal Decomposition of Device 28
Overheating of Device 27
Insufficient Information 24
No Audible Alarm 23
Use of Device Problem 22
Device Displays Incorrect Message 21
Improper or Incorrect Procedure or Method 19
Electrical /Electronic Property Problem 17
Device Emits Odor 14
Failure to Power Up 14
Gas Output Problem 13
Concentrator 13
Noise, Audible 13
Device Inoperable 13
Smoking 12
Mechanical Problem 11
Battery Problem 11
Unexpected Shutdown 10
Melted 10
Power Switch 9
Infusion or Flow Problem 9
Defective Alarm 9
No Apparent Adverse Event 8
Screen 7
PC (Printed Circuit) Board 7
Environmental Particulates 6
Failure to Deliver 5
Power Problem 5
Improper Flow or Infusion 5
Insufficient Flow or Under Infusion 5
Sparking 5
Electrical Shorting 5
Explosion 5
Failure to Charge 4
Contamination 4
Output Problem 4
Switch, Push Button 4
Appropriate Term/Code Not Available 4
Leak/Splash 4
No Display/Image 4
Temperature Problem 4
No Flow 4
Defective Device 4
Wire 3
Connection Problem 3
Material Discolored 3
Loose or Intermittent Connection 3
Circuit Failure 2
Diode 2
Compressor 2
Device Component Or Accessory 2
Component Missing 2
Charging Problem 2
Unit 2
Human-Device Interface Problem 2
Detachment of Device or Device Component 2
Off-Label Use 2
Battery 2
Power Cord 2
Product Quality Problem 2
Patient Device Interaction Problem 2
Fluid Leak 2
Cord 2
Detachment Of Device Component 2
Sticking 2
Filter 2
Spring 1
Premature Discharge of Battery 1
Self-Activation or Keying 1
Output below Specifications 1
Device Contamination with Chemical or Other Material 1
Human Factors Issue 1
Improper Device Output 1
Device Stops Intermittently 1
Out-Of-Box Failure 1
Dent in Material 1
Crack 1
Filling Problem 1
Material Separation 1
Inadequate Service 1
Inadequate Lighting 1
Installation-Related Problem 1
Programming Issue 1
Function Indicator Light 1
Excessive Heating 1
Failure to Sense 1
Cut In Material 1
Flare or Flash 1
Improper Alarm 1
Material Deformation 1
Unintended Movement 1
Electrical Wire 1
Total Device Problems 1130

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 Oxysure Systems, Inc. II Jul-24-2015

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