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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 105
Fire 84
Break 56
Device Operates Differently Than Expected 52
Loss of Power 42
Display 42
Device Operational Issue 38
Overheating of Device 25
Thermal Decomposition of Device 24
No Audible Alarm 23
Insufficient Information 23
Use of Device Problem 22
Device Displays Incorrect Message 21
Improper or Incorrect Procedure or Method 19
Electrical /Electronic Property Problem 16
Device Emits Odor 14
Failure to Power Up 14
Gas output problem 13
Concentrator 13
Device Inoperable 13
Noise, Audible 12
Mechanical Problem 11
Smoking 10
Battery Problem 10
Unexpected Shutdown 9
Melted 9
Power Switch 9
Defective Alarm 9
Infusion or Flow Problem 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 During Use 4
Output Problem 4
Switch, Push Button 4
No Display / Image 4
Leak / Splash 4
Temperature Problem 4
No Flow 4
Defective Device 4
Wire 3
Connection Problem 3
Loose or Intermittent Connection 3
Appropriate Term/Code Not Available 3
Device Component Or Accessory 2
Component Missing 2
Diode 2
Compressor (Air Pump) 2
Unit 2
Charging Problem 2
Material Discolored 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
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
Fluid Leak 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
Device Handling Problem 1
Total Device Problems 1107

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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