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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
  1.  K043006  MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; ...
  2.  K061261  L4 OXYGEN CONCENTRATOR
  3.  K081206  HOMELOX
  4.  K091028  OMNI 5 TOTAL O2 DELIVERY SYSTEM
  5.  K091191  GAS TRANSFILL
  6.  K111885  SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
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
  1.  K043006  MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; ...
  2.  K061261  L4 OXYGEN CONCENTRATOR
  3.  K081206  HOMELOX
  4.  K091028  OMNI 5 TOTAL O2 DELIVERY SYSTEM
  5.  K091191  GAS TRANSFILL
  6.  K111885  SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
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 48
Loss of power 43
No Known Device Problem 23
Device displays error message 21
Not audible alarm 20
Fire 15
Failure to power-up 14
Improper or incorrect procedure or method 11
Device inoperable 10
Improper gas output 10
Mechanical issue 7
Device emits odor 7
Defective Alarm 7
Burn of device or device component 7
Electrical issue 7
Use of Device Issue 7
Noise, Audible 6
Spark 5
Battery issue 5
No Information 5
Smoking 5
Melted 4
Leak 4
Contamination during use 4
No display or display failure 4
Output issue 4
Defective item 4
Insufficient flow or underinfusion 4
Connection issue 3
Improper flow or infusion 3
Failure to charge 3
Overheating of device or device component 3
Sticking 2
Device stops intermittently 2
User used incorrect product for intended use 2
Product quality issue 2
Explode 2
Improper device output 2
No code available 2
Device Issue 2
Cut in material 2
Component missing 2
Out-of-box failure 1
Failure to deliver 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Defective component 1
Invalid sensing 1
Dent in material 1
Malposition of device 1
Delivery system failure 1
Charging issue 1
Communication or transmission issue 1
Device handling issue 1
Programming issue 1
Temperature issue 1
Output below specifications 1
Inadequate lighting 1
Issue with displayed error message 1
Moisture or humidity problem 1
Naturally worn 1
Electrical shorting 1
Failure to shut off 1
Foreign material present in device 1
Human-Device Interface Issue 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
Self-activation or keying 1
Failure to sense 1
Inadequate service 1
Peeled 1
Loose or intermittent connection 1
Moisture damage 1
Instruction for use issue 1
Inaccurate flowrate 1
Fluid leak 1
Total Device Problems 621

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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