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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, continuous, facility use
Regulation Description Continuous ventilator.
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AIRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ALLIED HEALTHCARE PRODUCTS, INC.
  2
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 12
BIO-MED
  1
  SUBSTANTIALLY EQUIVALENT 7
BIRD PRODUCTS
  5
  SUBSTANTIALLY EQUIVALENT 16
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
Cardiopulmonary Corp.
  3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 12
DRAEGER MEDICAL
  1
  SUBSTANTIALLY EQUIVALENT 24
EVENT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2
HAMILTON
  2
  SUBSTANTIALLY EQUIVALENT 27
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 5
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 7
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  14
  SUBSTANTIALLY EQUIVALENT 25
NEWPORT
  3
  SUBSTANTIALLY EQUIVALENT 14
OCEANIC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  1
  SUBSTANTIALLY EQUIVALENT 9
PERCUSSIONAIRE CORP.
  2
  SUBSTANTIALLY EQUIVALENT 6
PULMONETIC SYSTEMS, INC.
  1
  SUBSTANTIALLY EQUIVALENT 11
RESMED
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS, INC.
  1
  SUBSTANTIALLY EQUIVALENT 21
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 3
SECHRIST INDUSTRIES, INC.
  1
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS
  3
  SUBSTANTIALLY EQUIVALENT 15
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
VERSAMED INC.
  SUBSTANTIALLY EQUIVALENT 8
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 4080
Incorrect or inadequate test results 1328
No code available 1321
Failure to charge 1056
Device operates differently than expected 931
Device inoperable 879
No display or display failure 713
Battery issue 688
Malfunction 683
Failure to power-up 420
Failure to cycle 305
Device alarm system issue 295
Failure to deliver 268
Not audible alarm 196
Inaccurate delivery 181
Electrical issue 169
No Known Device Problem 159
Self-activation or keying 152
Failure to run on AC/DC 132
Smoking 131
Increase in pressure 122
Device stops intermittently 119
Erratic display 117
Incorrect display 113
Failure to run on portable mode 113
Break 111
Leak 109
Pressure issue 88
Mechanical issue 87
Failure to calibrate 83
Loss of power 81
Detachment of device component 77
Tidal volume fluctuations 72
Device Issue 70
Unintended collision 66
Crack 66
Volume accuracy issue 64
Battery failure 62
Connection issue 62
Noise, Audible 62
Device emits odor 60
Improper device output 58
Power source issue 57
Charging issue 57
Infusion or flow issue 56
Occlusion within device 53
Contamination during use 50
Calibration issue 48
Premature discharge of battery 45
Decrease in pressure 39
Alarm, failure of warning 38
Use of Device Issue 37
Image display error 36
Low battery 36
Unknown (for use when the device problem is not known) 35
Gas delivery system failure 35
Disconnection 34
Other (for use when an appropriate device code cannot be identified) 32
No flow 32
No Information 30
Improper gas output 27
Defective Alarm 24
Device maintenance issue 24
Failure of device to self-test 24
Device sensing issue 23
Defective component 23
Delayed alarm 23
Alarm not visible 21
Application interface becomes non-functional or program exits abnormally 21
Loose or intermittent connection 20
Improper flow or infusion 20
Ventilation issue in device environment 19
Inappropriate or unexpected reset 18
Low audible alarm 18
Suction issue 16
Valve(s), failure of 16
Out-of-box failure 15
Computer operating system issue 14
Difficult to Program or Calibrate 14
Air leak 14
False alarm 12
Material fragmentation 11
Transducer failure 11
Poor quality image 11
Alarm system, failure of message-battery status 10
Sticking 10
Fire 10
Calibration error 10
Communication or transmission issue 10
Deployment issue 10
Aborted charge 9
Burn of device or device component 9
Circuit Failure 8
Component(s), broken 8
Alarm, error of warning 8
Corrosion 8
Failure to shut off 8
Foreign material present in device 7
Delamination 7
Excess flow or overinfusion 7
Total Device Problems 17277

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 6 5 9 6 3
Class II 7 11 5 6 10 2 3 5 5 5
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomed Devices II Jan-27-2011
2 Cardinal Health 203, Inc II Aug-13-2008
3 CareFusion 203, Inc. I Sep-19-2014
4 CareFusion 203, Inc. I Jul-16-2012
5 CareFusion 203, Inc. I Oct-26-2011
6 CareFusion 203, Inc. II Aug-10-2010
7 CareFusion 203, Inc. II Feb-25-2010
8 Carefusion 211 Inc I Jan-11-2012
9 Carefusion 211 Inc dba Carefusion I Jun-13-2016
10 Carefusion 211 Inc dba Carefusion I May-26-2015
11 Carefusion 211 Inc dba Carefusion I Sep-27-2013
12 Covidien I Jan-03-2014
13 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
14 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
15 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
16 Covidien Limited II Sep-16-2008
17 Datex - Ohmeda, Inc II Aug-16-2008
18 Datex - Ohmeda, Inc II May-10-2007
19 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
20 Del Mar Reynolds Medical, Ltd. I Apr-12-2014
21 Del Mar Reynolds Medical, Ltd. II Jul-19-2013
22 Del Mar Reynolds Medical, Ltd. I Mar-20-2013
23 Draeger Medical Systems, Inc. I Mar-28-2014
24 Draeger Medical Systems, Inc. II Oct-07-2010
25 Draeger Medical, Inc. I Feb-25-2016
26 Draeger Medical, Inc. I Feb-03-2016
27 Draeger Medical, Inc. I Dec-23-2015
28 Draeger Medical, Inc. I Aug-14-2015
29 Draeger Medical, Inc. II May-14-2009
30 Draeger Medical, Inc. II Oct-27-2008
31 Draeger Medical, Inc. II Sep-20-2008
32 Event Medical LTD I Nov-19-2015
33 Flight Medical Ltd. I Feb-21-2012
34 GE Healthcare II Mar-24-2015
35 GE Healthcare II Sep-24-2008
36 GE Healthcare, LLC I Jun-17-2012
37 GE Medical Systems, LLC II Jan-21-2016
38 Hamilton Medical Inc I Jan-31-2013
39 Hamilton Medical Inc II Mar-07-2012
40 Hamilton Medical Inc II Apr-08-2011
41 Hamilton Medical, Inc. II May-09-2016
42 Hamilton Medical, Inc. I Nov-04-2015
43 Hamilton Medical, Inc. II Jul-10-2015
44 Hamilton Medical, Inc. II Nov-06-2013
45 Impact Instrumentation, Inc. III Aug-07-2012
46 Impact Instrumentation, Inc. II Aug-29-2011
47 MAQUET Inc. II Jan-05-2010
48 MAQUET Inc. II May-12-2009
49 MAQUET Inc. II Feb-03-2009
50 MAQUET Inc. II Sep-23-2008
51 MAQUET Inc. II Feb-10-2007
52 MAQUET Inc. II Jan-25-2007
53 Maquet Cardiovascular Us Sales, Llc I Apr-26-2013
54 Maquet Inc. II Apr-03-2012
55 Maquet Inc. II Dec-02-2011
56 Maquet Inc. II Jun-23-2011
57 Nellcor Puritan Bennett II Apr-24-2007
58 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Dec-09-2014
59 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Oct-28-2014
60 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-20-2014
61 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-17-2014
62 Nellcor Puritan Bennett Inc. (dba Covidien LP) II May-09-2014
63 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jan-24-2014
64 Newport Medical Instruments Inc I Apr-14-2014
65 Newport Medical Instruments Inc I Apr-26-2013
66 Newport Medical Instruments Inc II Jun-08-2011
67 Newport Medical Instruments Inc II Jun-02-2011
68 Newport Medical Instruments Inc II May-27-2011
69 Newport Medical Instruments Inc II May-26-2011
70 Newport Medical Instruments Inc II May-26-2011
71 Newport Medical Instruments Inc II May-19-2010
72 Newport Medical Instruments Inc II Sep-04-2009
73 Newport Medical Instruments Inc II Sep-19-2007
74 Philips Respironics II Mar-07-2016
75 Phillips Respironics, Inc. I Mar-06-2014
76 ResMed Ltd. II Jun-10-2015
77 Resmed Corporation II Feb-03-2016
78 Respironics California Inc II Dec-01-2014
79 Respironics California Inc I Oct-21-2014
80 Respironics California Inc II Aug-26-2013
81 Respironics California Inc II Aug-11-2009
82 Respironics California Inc II Sep-17-2008
83 Respironics, Inc. I Jul-23-2012
84 Respironics, Inc. I Jan-11-2012
85 Respironics, Inc. II Jun-24-2010
86 Respironics, Inc. II Sep-18-2008
87 Respironics, Inc. II Apr-24-2008
88 Viasys Respiratory Care, Inc. II Jan-11-2007
89 Viasys Respiratory Care, Inc.dba Bird Products II May-14-2008
90 Viasys Respiratory Care, Inc.dba Bird Products II Mar-20-2007

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