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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 17
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 56
Device operates differently than expected 48
No Known Device Problem 47
Loss of power 43
Fire 22
Device displays error message 21
Not audible alarm 20
Failure to power-up 14
Improper or incorrect procedure or method 14
Use of Device Issue 11
Device inoperable 10
Improper gas output 10
Burn of device or device component 9
Electrical issue 8
Defective Alarm 7
Mechanical issue 7
Device emits odor 7
Noise, Audible 6
No Information 5
Smoking 5
Spark 5
Battery issue 5
Defective item 4
Improper flow or infusion 4
Insufficient flow or underinfusion 4
Overheating of device or device component 4
Melted 4
Leak 4
Contamination during use 4
No display or display failure 4
Output issue 4
Failure to charge 3
Connection issue 3
Improper device output 2
Component missing 2
Failure to deliver 2
Device Issue 2
Cut in material 2
Explode 2
Sticking 2
Device stops intermittently 2
User used incorrect product for intended use 2
Product quality issue 2
No code available 2
Device handling issue 1
Programming issue 1
Temperature issue 1
Output below specifications 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
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
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Device damaged prior to use 1
Defective component 1
Invalid sensing 1
Delivery system failure 1
Inadequate lighting 1
Issue with displayed error message 1
Maintenance does not comply to manufacturers recommendations 1
Medical Gas Supply problem 1
Moisture or humidity problem 1
Naturally worn 1
Charging issue 1
Communication or transmission issue 1
Malposition of device 1
Electrical shorting 1
Failure to shut off 1
Foreign material present in device 1
Human-Device Interface Issue 1
Total Device Problems 669

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 0 0 0 1 0 0 0 0 0
Class II 0 2 2 0 1 0 1 3 1 1 0
Class III 0 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 Inovo, Inc II Dec-14-2016
3 Invacare Corporation II Dec-24-2014
4 Invacare Corporation II Dec-12-2014
5 Invacare Corporation II Feb-24-2011
6 Medline Industries Inc II Jul-23-2008
7 Nidek Medical Products Inc I Jun-19-2012
8 On Site Gas Systems Inc. II Jan-08-2014
9 Oxus America, Inc. II Feb-02-2013
10 Oxysure Systems, Inc. II Jul-24-2015
11 Pacific Consolidated Industries LLC I Aug-28-2008
12 Sequal Technologies Inc II Dec-23-2009
13 Sunrise Medical II Dec-30-2008

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