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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 29
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 5122
Incorrect or inadequate test results 1868
No code available 1598
Failure to charge 1538
Device operates differently than expected 1282
Device inoperable 1271
No display or display failure 1084
Battery issue 1051
Malfunction 684
Failure to power-up 514
Failure to calibrate 456
Device alarm system issue 379
Failure to cycle 311
Failure to deliver 270
No Known Device Problem 254
Electrical issue 217
Not audible alarm 210
Erratic display 207
Inaccurate delivery 186
Leak 166
Power source issue 163
Self-activation or keying 157
Device stops intermittently 151
Mechanical issue 150
Failure to run on AC/DC 143
Smoking 135
Break 131
Pressure issue 131
Increase in pressure 123
Incorrect display 114
Failure to run on portable mode 113
Loss of power 105
Tidal volume fluctuations 95
Charging issue 86
Volume accuracy issue 85
Detachment of device component 78
Crack 75
Occlusion within device 75
Device Issue 75
Noise, Audible 75
Connection issue 71
Infusion or flow issue 66
Unintended collision 66
Device emits odor 62
Battery failure 62
Contamination during use 61
No Information 60
Calibration issue 59
Improper device output 59
Premature discharge of battery 58
Disconnection 48
Suction issue 44
Communication or transmission issue 43
Decrease in pressure 39
Use of Device Issue 38
Alarm, failure of warning 38
Low battery 37
Image display error 36
Gas delivery system failure 35
Unknown (for use when the device problem is not known) 35
No flow 35
Device sensing issue 34
Other (for use when an appropriate device code cannot be identified) 32
Inappropriate or unexpected reset 32
Defective Alarm 31
Aborted charge 30
Improper gas output 27
Failure of device to self-test 25
Ventilation issue in device environment 24
Alarm not visible 24
Delayed alarm 24
Device maintenance issue 24
Defective component 23
Loose or intermittent connection 22
Application interface becomes non-functional or program exits abnormally 21
Improper flow or infusion 21
Low audible alarm 19
Air leak 16
Valve(s), failure of 16
Calibration error 15
Out-of-box failure 15
Computer operating system issue 14
Difficult to Program or Calibrate 14
Excess flow or overinfusion 13
False alarm 13
Failure to shut off 13
Burn of device or device component 11
Material fragmentation 11
Poor quality image 11
Transducer failure 11
Sticking 10
Alarm system, failure of message-battery status 10
Fire 10
Deployment issue 10
High Readings 10
Low readings 10
Reset issue 10
Component falling 9
Circuit Failure 9
Failure to sense 9
Total Device Problems 22663

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

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