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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 185
Break 56
No Known Device Problem 56
Device operates differently than expected 49
Loss of power 43
Fire 38
Device displays error message 22
Not audible alarm 20
Improper or incorrect procedure or method 17
Use of Device Issue 14
Failure to power-up 14
Device inoperable 13
Burn of device or device component 12
Electrical issue 10
Improper gas output 10
No Information 10
Device emits odor 8
Mechanical issue 7
Defective Alarm 7
Battery issue 6
Noise, Audible 6
Spark 5
Melted 5
Overheating of device or device component 5
Smoking 5
Leak 4
Failure to charge 4
Contamination during use 4
No display or display failure 4
Defective item 4
Improper flow or infusion 4
Insufficient flow or underinfusion 4
Output issue 4
Connection issue 3
Fluid leak 2
Component missing 2
Failure to deliver 2
Device Issue 2
Cut in material 2
Explode 2
Detachment of device component 2
Sticking 2
Device stops intermittently 2
User used incorrect product for intended use 2
Product quality issue 2
Electrical shorting 2
Improper device output 2
No code available 2
Device handling issue 1
Output below specifications 1
Environmental Particulates 1
Extrusion 1
Failure to shut off 1
Foreign material present in device 1
Human-Device Interface Issue 1
Power source issue 1
Programming issue 1
Temperature issue 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
Premature discharge of battery 1
False reading from device non-compliance 1
Filling problem 1
Failure to run on AC/DC 1
Crack 1
Dent in material 1
Failure to separate 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
Charging issue 1
Communication or transmission issue 1
Malposition of device 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
No flow 1
Total Device Problems 729

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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