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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
  1.  K141967  PUREFILL OXYGEN COMPRESSOR
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
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
Improper or Incorrect Procedure or Method 21
Thermal Decomposition of Device 21
Use of Device Problem 19
Overheating of Device 16
Failure to Power Up 14
Concentrator 13
Device Emits Odor 13
Insufficient Information 13
Gas output problem 13
Device Inoperable 13
Electrical /Electronic Property Problem 12
Noise, Audible 11
Mechanical Problem 10
Power Switch 9
Melted 9
Battery Problem 9
Defective Alarm 8
Unexpected Shutdown 8
PC (Printed Circuit) Board 7
No Apparent Adverse Event 7
Screen 7
Smoking 6
Infusion or Flow Problem 6
Sparking 5
Contamination During Use 5
Environmental Particulates 5
Insufficient Flow or Under Infusion 5
Improper Flow or Infusion 5
Defective Device 4
Output Problem 4
Switch, Push Button 4
Leak / Splash 4
Electrical Shorting 4
Failure to Charge 4
No Display / Image 4
Appropriate Term/Code Not Available 4
Failure to Deliver 4
No Flow 3
Wire 3
Connection Problem 3
Power Problem 3
Loose or Intermittent Connection 3
Filter 3
Cut In Material 2
Detachment Of Device Component 2
Diode 2
Power Cord 2
Sticking 2
Device Issue 2
Compressor (Air Pump) 2
Off-Label Use 2
Improper Device Output 2
Material Discolored 2
Product Quality Problem 2
Human-Device Interface Problem 2
Unit 2
Explosion 2
Cord 2
Component Missing 2
Manifold 1
Activation, Positioning or Separation Problem 1
Inadequate Lighting 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Extrusion 1
Output below Specifications 1
Function Indicator 1
Premature Discharge of Battery 1
Circuit Failure 1
Self-Activation or Keying 1
Inadequate Service 1
Invalid Sensing 1
Programming Issue 1
Device Component Or Accessory 1
Function Indicator Light 1
Unintended Electrical Shock 1
Communication or Transmission Problem 1
Gas Leak 1
False Reading From Device Non-Compliance 1
Failure to Sense 1
Device Stops Intermittently 1
Alarm, Visual 1
Battery 1
Circuit Board 1
Valve 1
Issue With Displayed Error Message 1
Medical Gas Supply Problem 1
Charging Problem 1
Defective Component 1
Material Separation 1
Out-Of-Box Failure 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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