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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
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ESSEX CRYOGENICS OF MISSOURI, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K160630  Invacare Platinum Mobile Oxygen Concentrator
  2.  K191159  Concentrator with Single battery pack, carry bag w ...
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMTC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Alarm System 185
Adverse Event Without Identified Device or Use Problem 96
Fire 79
Break 56
Device Operates Differently Than Expected 52
Loss of Power 43
Display 42
Device Operational Issue 40
Device Displays Incorrect Message 23
No Audible Alarm 23
Thermal Decomposition of Device 21
Improper or Incorrect Procedure or Method 21
Use of Device Problem 19
Overheating of Device 16
Failure to Power Up 14
Gas output problem 13
Device Emits Odor 13
Device Inoperable 13
Concentrator 13
Insufficient Information 13
Electrical /Electronic Property Problem 12
Noise, Audible 11
Mechanical Problem 10
Melted 9
Power Switch 9
Battery Problem 9
Unexpected Shutdown 8
Defective Alarm 8
Screen 7
PC (Printed Circuit) Board 7
No Apparent Adverse Event 7
Infusion or Flow Problem 6
Smoking 6
Insufficient Flow or Under Infusion 5
Contamination During Use 5
Improper Flow or Infusion 5
Sparking 5
Environmental Particulates 5
Defective Device 4
Electrical Shorting 4
Switch, Push Button 4
Appropriate Term/Code Not Available 4
Output Problem 4
No Display / Image 4
Failure to Charge 4
Failure to Deliver 4
Leak / Splash 4
Loose or Intermittent Connection 3
Filter 3
Wire 3
Power Problem 3
No Flow 3
Connection Problem 3
Component Missing 2
Improper Device Output 2
Human-Device Interface Problem 2
Unit 2
Explosion 2
Diode 2
Power Cord 2
Compressor (Air Pump) 2
Cord 2
Detachment Of Device Component 2
Material Discolored 2
Off-Label Use 2
Product Quality Problem 2
Device Issue 2
Cut In Material 2
Sticking 2
Device Stops Intermittently 1
Stretched 1
Peeled / Delaminated 1
Dent in Material 1
Separation Failure 1
Arcing 1
Fitting Problem 1
Material Perforation 1
Device Damaged Prior to Use 1
Defective Component 1
Invalid Sensing 1
Self-Activation or Keying 1
Failure to Sense 1
Material Separation 1
Inadequate Service 1
Moisture Damage 1
False Reading From Device Non-Compliance 1
Filling Problem 1
Fluid Leak 1
Crack 1
Premature Discharge of Battery 1
Circuit Failure 1
Spring 1
Plug 1
Valve 1
Function Indicator 1
Manifold 1
Battery 1
Circuit Board 1
Alarm 1
Alarm, LED 1
Total Device Problems 1046

Recalls
Manufacturer Recall Class Date Posted
1 Inovo, Inc II Jan-24-2018
2 Inovo, Inc II Dec-14-2016
3 Invacare Corporation II Dec-24-2014
4 Invacare Corporation II Dec-12-2014
5 On Site Gas Systems Inc. II Jan-08-2014
6 Oxysure Systems, Inc. II Jul-24-2015

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