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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 28
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 4675
Incorrect or inadequate test results 1692
No code available 1543
Failure to charge 1430
Device operates differently than expected 1197
Device inoperable 990
No display or display failure 882
Battery issue 838
Malfunction 684
Failure to power-up 472
Device alarm system issue 350
Failure to cycle 307
Failure to deliver 268
No Known Device Problem 235
Electrical issue 208
Not audible alarm 201
Failure to calibrate 191
Inaccurate delivery 184
Self-activation or keying 153
Leak 145
Mechanical issue 144
Failure to run on AC/DC 138
Smoking 132
Device stops intermittently 129
Break 127
Increase in pressure 123
Erratic display 118
Incorrect display 113
Failure to run on portable mode 113
Pressure issue 111
Power source issue 92
Loss of power 84
Tidal volume fluctuations 84
Detachment of device component 77
Device Issue 73
Charging issue 70
Connection issue 70
Crack 67
Volume accuracy issue 67
Unintended collision 66
Battery failure 62
Noise, Audible 62
Infusion or flow issue 60
Contamination during use 60
Device emits odor 60
Improper device output 58
Premature discharge of battery 56
Occlusion within device 53
Calibration issue 50
Disconnection 40
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
Suction issue 33
No flow 33
Other (for use when an appropriate device code cannot be identified) 32
No Information 31
Improper gas output 27
Defective Alarm 26
Inappropriate or unexpected reset 26
Failure of device to self-test 24
Delayed alarm 24
Device maintenance issue 24
Device sensing issue 23
Defective component 23
Ventilation issue in device environment 22
Alarm not visible 22
Application interface becomes non-functional or program exits abnormally 21
Loose or intermittent connection 21
Improper flow or infusion 21
Low audible alarm 19
Valve(s), failure of 16
Aborted charge 16
Out-of-box failure 15
Computer operating system issue 14
Difficult to Program or Calibrate 14
Air leak 14
False alarm 13
Calibration error 11
Material fragmentation 11
Transducer failure 11
Poor quality image 11
Communication or transmission issue 11
Deployment issue 10
Alarm system, failure of message-battery status 10
Sticking 10
Fire 10
Burn of device or device component 9
Excess flow or overinfusion 9
Failure to shut off 9
Circuit Failure 8
Component(s), broken 8
Alarm, error of warning 8
Corrosion 8
Component falling 7
Overheating of device or device component 7
Total Device Problems 20182

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 6 5 9 6 4 0
Class II 7 11 5 6 10 2 3 5 5 6 0
Class III 0 0 0 0 0 1 0 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 Aug-04-2016
26 Draeger Medical, Inc. I Feb-25-2016
27 Draeger Medical, Inc. I Feb-03-2016
28 Draeger Medical, Inc. I Dec-23-2015
29 Draeger Medical, Inc. I Aug-14-2015
30 Draeger Medical, Inc. II May-14-2009
31 Draeger Medical, Inc. II Oct-27-2008
32 Draeger Medical, Inc. II Sep-20-2008
33 Event Medical LTD I Nov-19-2015
34 Flight Medical Ltd. I Feb-21-2012
35 GE Healthcare II Mar-24-2015
36 GE Healthcare II Sep-24-2008
37 GE Healthcare, LLC I Jun-17-2012
38 GE Medical Systems, LLC II Jan-21-2016
39 Hamilton Medical Inc I Jan-31-2013
40 Hamilton Medical Inc II Mar-07-2012
41 Hamilton Medical Inc II Apr-08-2011
42 Hamilton Medical, Inc. II Nov-28-2016
43 Hamilton Medical, Inc. II May-09-2016
44 Hamilton Medical, Inc. I Nov-04-2015
45 Hamilton Medical, Inc. II Jul-10-2015
46 Hamilton Medical, Inc. II Nov-06-2013
47 Impact Instrumentation, Inc. III Aug-07-2012
48 Impact Instrumentation, Inc. II Aug-29-2011
49 MAQUET Inc. II Jan-05-2010
50 MAQUET Inc. II May-12-2009
51 MAQUET Inc. II Feb-03-2009
52 MAQUET Inc. II Sep-23-2008
53 MAQUET Inc. II Feb-10-2007
54 MAQUET Inc. II Jan-25-2007
55 Maquet Cardiovascular Us Sales, Llc I Apr-26-2013
56 Maquet Inc. II Apr-03-2012
57 Maquet Inc. II Dec-02-2011
58 Maquet Inc. II Jun-23-2011
59 Nellcor Puritan Bennett II Apr-24-2007
60 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Dec-09-2014
61 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Oct-28-2014
62 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-20-2014
63 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-17-2014
64 Nellcor Puritan Bennett Inc. (dba Covidien LP) II May-09-2014
65 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jan-24-2014
66 Newport Medical Instruments Inc I Apr-14-2014
67 Newport Medical Instruments Inc I Apr-26-2013
68 Newport Medical Instruments Inc II Jun-08-2011
69 Newport Medical Instruments Inc II Jun-02-2011
70 Newport Medical Instruments Inc II May-27-2011
71 Newport Medical Instruments Inc II May-26-2011
72 Newport Medical Instruments Inc II May-26-2011
73 Newport Medical Instruments Inc II May-19-2010
74 Newport Medical Instruments Inc II Sep-04-2009
75 Newport Medical Instruments Inc II Sep-19-2007
76 Philips Respironics II Mar-07-2016
77 Phillips Respironics, Inc. I Mar-06-2014
78 ResMed Ltd. II Jun-10-2015
79 Resmed Corporation II Feb-03-2016
80 Respironics California Inc II Dec-01-2014
81 Respironics California Inc I Oct-21-2014
82 Respironics California Inc II Aug-26-2013
83 Respironics California Inc II Aug-11-2009
84 Respironics California Inc II Sep-17-2008
85 Respironics, Inc. I Jul-23-2012
86 Respironics, Inc. I Jan-11-2012
87 Respironics, Inc. II Jun-24-2010
88 Respironics, Inc. II Sep-18-2008
89 Respironics, Inc. II Apr-24-2008
90 Viasys Respiratory Care, Inc. II Jan-11-2007
91 Viasys Respiratory Care, Inc.dba Bird Products II May-14-2008
92 Viasys Respiratory Care, Inc.dba Bird Products II Mar-20-2007

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