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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
  SUBSTANTIALLY EQUIVALENT 2
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 8
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAIRE
  SUBSTANTIALLY EQUIVALENT 2
COLORADO MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
DELPHI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
EMG
  SUBSTANTIALLY EQUIVALENT 1
EVEREST & JENNINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 16
LIF-O-GEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MADA EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
MERITS
  SUBSTANTIALLY EQUIVALENT 5
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 4
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SEQUAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 8
ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device alarm system issue 184
Break 55
Device operates differently than expected 44
Loss of power 43
Device displays error message 21
Not audible alarm 20
Failure to power-up 14
No Known Device Problem 14
Fire 12
Improper or incorrect procedure or method 11
Device inoperable 10
Improper gas output 10
Mechanical issue 7
Defective Alarm 7
Electrical issue 7
Use of Device Issue 7
Device emits odor 6
Noise, Audible 6
Burn of device or device component 5
Smoking 5
Spark 5
Battery issue 5
Insufficient flow or underinfusion 4
Output issue 4
Defective item 4
Contamination during use 4
No display or display failure 4
Leak 4
No Information 4
Melted 3
Overheating of device or device component 3
Failure to charge 3
Connection issue 3
Improper flow or infusion 3
Improper device output 2
Sticking 2
Device stops intermittently 2
Component missing 2
Device Issue 2
Cut in material 2
Explode 2
Product quality issue 2
No code available 2
Device handling issue 1
Self-activation or keying 1
Failure to sense 1
Inadequate service 1
Peeled 1
User used incorrect product for intended use 1
Moisture damage 1
Loose or intermittent connection 1
Instruction for use issue 1
Inaccurate flowrate 1
Fluid leak 1
False reading from device non-compliance 1
Filling problem 1
Failure to run on AC/DC 1
Crack 1
Detachment of device component 1
Premature discharge of battery 1
Dent in material 1
Out-of-box failure 1
Failure to deliver 1
Charging issue 1
Communication or transmission issue 1
Malposition of device 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Defective component 1
Invalid sensing 1
Delivery system failure 1
Electrical shorting 1
Failure to shut off 1
Foreign material present in device 1
Inadequate lighting 1
Issue with displayed error message 1
Moisture or humidity problem 1
Naturally worn 1
Programming issue 1
Temperature issue 1
Output below specifications 1
Total Device Problems 598

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 0 0 0 1 0 0 0 0
Class II 0 2 2 0 1 0 1 3 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Carleton Life Support Systems Inc II Sep-16-2009
2 Invacare Corporation II Dec-24-2014
3 Invacare Corporation II Dec-12-2014
4 Invacare Corporation II Feb-24-2011
5 Medline Industries Inc II Jul-23-2008
6 Nidek Medical Products Inc I Jun-19-2012
7 On Site Gas Systems Inc. II Jan-08-2014
8 Oxus America, Inc. II Feb-02-2013
9 Oxysure Systems, Inc. II Jul-24-2015
10 Pacific Consolidated Industries LLC I Aug-28-2008
11 Sequal Technologies Inc II Dec-23-2009
12 Sunrise Medical II Dec-30-2008

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