• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 3
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
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 6344
Incorrect or inadequate test results 2183
Device operates differently than expected 1970
Device inoperable 1901
No code available 1703
No display or display failure 1624
Failure to charge 1622
Battery issue 1439
Failure to calibrate 875
Malfunction 684
Failure to power-up 611
Device alarm system issue 457
Erratic display 389
Power source issue 342
Failure to cycle 316
No Known Device Problem 288
Failure to deliver 278
Leak 248
Not audible alarm 231
Electrical issue 224
Device stops intermittently 211
Inaccurate delivery 206
Charging issue 198
Pressure issue 164
Self-activation or keying 158
Mechanical issue 157
Noise, Audible 154
Failure to run on AC/DC 145
Break 139
Tidal volume fluctuations 137
Smoking 137
Increase in pressure 126
Loss of power 125
Occlusion within device 124
Incorrect display 117
Failure to run on portable mode 113
Volume accuracy issue 112
No Information 111
Device sensing issue 103
Communication or transmission issue 99
Calibration issue 98
Detachment of device component 80
Crack 76
Connection issue 76
Device Issue 75
Infusion or flow issue 70
Unintended collision 66
Device emits odor 65
Contamination during use 64
Suction issue 63
Battery failure 62
Premature discharge of battery 60
Improper device output 60
Disconnection 58
Low battery 46
Defective component 42
Decrease in pressure 42
Aborted charge 40
Inappropriate or unexpected reset 39
No flow 39
Image display error 39
Use of Device Issue 38
Alarm, failure of warning 38
Improper alarm 38
Failure of device to self-test 37
Defective Alarm 37
Gas delivery system failure 35
Unknown (for use when the device problem is not known) 35
Other (for use when an appropriate device code cannot be identified) 32
Improper gas output 30
Alarm not visible 29
Low readings 28
Improper flow or infusion 27
Burn of device or device component 27
Air leak 25
Loose or intermittent connection 25
Ventilation issue in device environment 25
Device maintenance issue 24
Delayed alarm 24
Calibration error 22
Application interface becomes non-functional or program exits abnormally 22
High Readings 22
Fire 19
Low audible alarm 19
Reset issue 18
Material deformation 16
Out-of-box failure 16
Component falling 16
Valve(s), failure of 16
Failure to shut off 15
No Pressure 14
Computer operating system issue 14
Difficult to Program or Calibrate 14
Excess flow or overinfusion 14
False alarm 13
Temperature issue 13
Poor quality image 12
Overheating of device or device component 12
Sticking 11
Failure to sense 11
Total Device Problems 28708

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

-
-