• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
ESSEX CRYOGENICS OF MISSOURI, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 97
Fire 80
Break 56
Device Operates Differently Than Expected 52
Loss of Power 43
Display 42
Device Operational Issue 40
No Audible Alarm 23
Device Displays Incorrect Message 23
Thermal Decomposition of Device 21
Improper or Incorrect Procedure or Method 21
Use of Device Problem 20
Overheating of Device 17
Failure to Power Up 14
Gas output problem 13
Concentrator 13
Insufficient Information 13
Device Inoperable 13
Device Emits Odor 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
No Apparent Adverse Event 7
Screen 7
PC (Printed Circuit) Board 7
Smoking 6
Infusion or Flow Problem 6
Insufficient Flow or Under Infusion 5
Sparking 5
Contamination During Use 5
Improper Flow or Infusion 5
Environmental Particulates 5
Failure to Deliver 4
Defective Device 4
Output Problem 4
Switch, Push Button 4
Failure to Charge 4
Leak / Splash 4
No Display / Image 4
Appropriate Term/Code Not Available 4
Electrical Shorting 4
Loose or Intermittent Connection 3
Connection Problem 3
Filter 3
No Flow 3
Power Problem 3
Wire 3
Power Cord 2
Cut In Material 2
Product Quality Problem 2
Device Issue 2
Improper Device Output 2
Cord 2
Detachment Of Device Component 2
Sticking 2
Unit 2
Material Discolored 2
Component Missing 2
Diode 2
Compressor (Air Pump) 2
Off-Label Use 2
Human-Device Interface Problem 2
Explosion 2
Separation Problem 1
Naturally Worn 1
Detachment of Device or device Component 1
Extrusion 1
Stretched 1
Device Damaged Prior to Use 1
Defective Component 1
Invalid Sensing 1
Arcing 1
Function Indicator 1
Circuit Failure 1
Valve 1
Separation Failure 1
Malposition of device 1
Failure to Shut Off 1
Issue With Displayed Error Message 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Material Distortion 1
Medical Gas Supply Problem 1
Device Component Or Accessory 1
False Reading From Device Non-Compliance 1
Moisture Damage 1
Alarm 1
Charging Problem 1
Material Perforation 1
Temperature Problem 1
Delivery System Failure 1
Activation, Positioning or Separation Problem 1
Device Unsafe to Use in Environment 1
Device Stops Intermittently 1
Fitting Problem 1
Total Device Problems 1050

Recalls
Manufacturer Recall Class Date Posted
1 Caire, Inc. II Oct-30-2019
2 Inovo, Inc II Jan-24-2018
3 Inovo, Inc II Dec-14-2016
4 Invacare Corporation II Dec-24-2014
5 Invacare Corporation II Dec-12-2014
6 On Site Gas Systems Inc. II Jan-08-2014
7 Oxysure Systems, Inc. II Jul-24-2015

-
-