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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 55
Device operates differently than expected 48
Loss of power 43
No Known Device Problem 38
Device displays error message 21
Not audible alarm 20
Fire 19
Failure to power-up 14
Improper or incorrect procedure or method 12
Device inoperable 10
Improper gas output 10
Use of Device Issue 8
Burn of device or device component 8
Defective Alarm 7
Mechanical issue 7
Device emits odor 7
Electrical issue 7
Noise, Audible 6
No Information 5
Smoking 5
Battery issue 5
Spark 5
Contamination during use 4
No display or display failure 4
Melted 4
Defective item 4
Overheating of device or device component 4
Output issue 4
Improper flow or infusion 4
Insufficient flow or underinfusion 4
Leak 4
Failure to charge 3
Connection issue 3
Failure to deliver 2
No code available 2
Component missing 2
Device stops intermittently 2
Improper device output 2
Product quality issue 2
Sticking 2
Device Issue 2
User used incorrect product for intended use 2
Cut in material 2
Explode 2
Filling problem 1
Failure to shut off 1
Fluid leak 1
Failure to run on AC/DC 1
Temperature issue 1
Material perforation 1
Instruction for use issue 1
Crack 1
Naturally worn 1
Delivery system failure 1
Moisture or humidity problem 1
Device damaged prior to use 1
Moisture damage 1
Malposition of device 1
Loose or intermittent connection 1
Out-of-box failure 1
Device handling issue 1
Peeled 1
Fitting problem 1
Detachment of device component 1
Foreign material present in device 1
Dent in material 1
Electrical shorting 1
Charging issue 1
Inaccurate flowrate 1
Defective component 1
Issue with displayed error message 1
Medical Gas Supply problem 1
Communication or transmission issue 1
False reading from device non-compliance 1
Human-Device Interface Issue 1
Programming issue 1
Failure to sense 1
Unknown (for use when the device problem is not known) 1
Maintenance does not comply to manufacturers recommendations 1
Inadequate lighting 1
Invalid sensing 1
Inadequate service 1
Premature discharge of battery 1
Output below specifications 1
Self-activation or keying 1
Total Device Problems 649

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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