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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
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH 207, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
COSMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 3
DIMAR S.P.A
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 2
DRAGER MEDICAL AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 4
FLIGHT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 18
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEVEL-5, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 4
NEWPORT MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
PAN-AMERICA HYPERBARICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE GLOBAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PULMONETIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS CALIFORNIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECME S.A.
  SUBSTANTIALLY EQUIVALENT 2
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERSAMED MEDICAL SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 2
VERSAMED MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7596 7596
2015 11874 11874
2016 16055 16055
2017 14451 14451
2018 9849 9849
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24957 24957
2024 13972 13972

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 15344 15344
Mechanical Problem 12833 12833
Output Problem 10376 10376
Device Operates Differently Than Expected 9862 9862
No Display/Image 8700 8700
Circuit Failure 7396 7396
Battery Problem 6792 6826
Device Inoperable 6042 6042
Failure to Recalibrate 4969 4969
Failure to Charge 4694 4710
Failure to Run on Battery 4108 4108
Failure to Calibrate 4016 4282
Defective Component 3939 3939
Failure to Power Up 3918 3918
Electrical /Electronic Property Problem 3902 3902
Incorrect Or Inadequate Test Results 2611 2611
Display or Visual Feedback Problem 2608 2608
Failure of Device to Self-Test 2426 2426
Device Operational Issue 2347 2347
Gas/Air Leak 2336 2336
Degraded 2318 2318
Appropriate Term/Code Not Available 2091 2091
Protective Measures Problem 2062 2101
Improper Flow or Infusion 2001 2001
Power Problem 1926 1968
Insufficient Information 1626 1626
Leak/Splash 1572 1572
No Flow 1531 1531
Failure to Deliver 1500 1500
Contamination 1490 1490
Unexpected Shutdown 1468 1468
Device Alarm System 1443 1443
Infusion or Flow Problem 1398 1398
Insufficient Flow or Under Infusion 1233 1233
Pressure Problem 1221 1221
Erratic or Intermittent Display 1185 1185
Adverse Event Without Identified Device or Use Problem 1180 1180
Loss of Power 1159 1159
Calibration Problem 1142 1142
Decrease in Pressure 1119 1119
Gas Output Problem 927 927
Break 862 862
Communication or Transmission Problem 841 841
Therapeutic or Diagnostic Output Failure 738 738
Tidal Volume Fluctuations 736 736
Charging Problem 712 712
Inaccurate Delivery 709 709
Noise, Audible 634 634
Application Program Problem 626 626
Complete Loss of Power 616 616

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65349 65349
No Patient Involvement 37609 37610
No Consequences Or Impact To Patient 25166 25567
No Known Impact Or Consequence To Patient 10951 10953
No Information 2950 2950
Insufficient Information 1764 1764
Low Oxygen Saturation 1369 1370
No Code Available 1161 1161
Death 725 725
Unspecified Respiratory Problem 515 515
Headache 345 345
Dyspnea 278 278
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 273 273
Dizziness 247 247
Cardiac Arrest 194 194
Respiratory Failure 181 181
Asthma 162 162
Cancer 157 157
Unspecified Kidney or Urinary Problem 129 129
Respiratory Tract Infection 128 128
Respiratory Insufficiency 125 125
Respiratory Distress 120 120
Hypoxia 113 113
Bradycardia 113 113
Nausea 111 111
Skin Inflammation/ Irritation 96 96
Vomiting 95 95
Cough 86 86
Ventilator Dependent 83 83
Inflammation 81 81
Cyanosis 80 80
Sore Throat 76 76
Pneumothorax 73 73
Hypersensitivity/Allergic reaction 71 71
Pneumonia 60 60
Unspecified Heart Problem 58 58
Hypoventilation 57 57
Patient Problem/Medical Problem 52 52
Respiratory Arrest 48 48
Low Blood Pressure/ Hypotension 47 47
Chronic Obstructive Pulmonary Disease (COPD) 45 45
Apnea 42 42
Loss of consciousness 41 41
Cardiopulmonary Arrest 40 40
Injury 40 40
Unspecified Hepatic or Biliary Problem 34 34
Discomfort 34 34
Increased Respiratory Rate 34 34
Tachycardia 31 31
Heart Failure/Congestive Heart Failure 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jun-26-2024
2 Baxter Healthcare Corporation I Feb-24-2023
3 Biomed Devices II Jan-27-2011
4 Breas Medical, Inc. II Apr-15-2022
5 COVIDIEN LLC I Dec-18-2018
6 CareFusion 203, Inc. I Sep-19-2014
7 CareFusion 203, Inc. I Jul-16-2012
8 CareFusion 203, Inc. I Oct-26-2011
9 CareFusion 203, Inc. II Aug-10-2010
10 CareFusion 203, Inc. II Feb-25-2010
11 Carefusion 211 Inc I Jan-11-2012
12 Carefusion 211 Inc dba Carefusion I Jun-13-2016
13 Carefusion 211 Inc dba Carefusion I May-26-2015
14 Carefusion 211 Inc dba Carefusion I Sep-27-2013
15 Covidien I Aug-02-2024
16 Covidien I Jan-03-2014
17 Covidien LLC II Mar-27-2018
18 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
19 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
20 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
21 Covidien Llc I Dec-09-2021
22 Covidien Llc II Nov-06-2020
23 Datex-Ohmeda, Inc. II Aug-08-2018
24 Datex-Ohmeda, Inc. II Jun-01-2018
25 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
26 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
27 Del Mar Reynolds Medical, Ltd. I Apr-12-2014
28 Del Mar Reynolds Medical, Ltd. II Jul-19-2013
29 Del Mar Reynolds Medical, Ltd. I Mar-20-2013
30 Draeger Medical Systems, Inc. I Mar-28-2014
31 Draeger Medical Systems, Inc. II Oct-07-2010
32 Draeger Medical, Inc. I Aug-18-2023
33 Draeger Medical, Inc. I Jul-08-2023
34 Draeger Medical, Inc. I Feb-24-2023
35 Draeger Medical, Inc. II Apr-04-2022
36 Draeger Medical, Inc. II Oct-14-2021
37 Draeger Medical, Inc. II May-28-2021
38 Draeger Medical, Inc. II May-29-2018
39 Draeger Medical, Inc. I Aug-04-2016
40 Draeger Medical, Inc. I Feb-25-2016
41 Draeger Medical, Inc. I Feb-03-2016
42 Draeger Medical, Inc. I Dec-23-2015
43 Draeger Medical, Inc. I Aug-14-2015
44 Draeger Medical, Inc. II May-14-2009
45 Event Medical LTD I Nov-19-2015
46 Flight Medical Ltd. I Feb-21-2012
47 GE Healthcare II Mar-24-2015
48 GE Healthcare, LLC I Jun-06-2022
49 GE Healthcare, LLC II Aug-24-2020
50 GE Healthcare, LLC II Dec-17-2019
51 GE Healthcare, LLC I Nov-30-2018
52 GE Healthcare, LLC I Jun-17-2012
53 GE Medical Systems, LLC II Jan-21-2016
54 Getinge Group Logistics America, LLC II Oct-09-2020
55 Getinge Usa Sales Inc II Aug-24-2022
56 Getinge Usa Sales Inc I Aug-22-2022
57 Hamilton Medical AG I Jun-18-2024
58 Hamilton Medical AG II Apr-25-2023
59 Hamilton Medical AG II Nov-18-2022
60 Hamilton Medical AG I Aug-19-2022
61 Hamilton Medical AG I Jul-11-2019
62 Hamilton Medical AG II Aug-14-2018
63 Hamilton Medical AG II Apr-12-2018
64 Hamilton Medical Inc I Jan-31-2013
65 Hamilton Medical Inc II Mar-07-2012
66 Hamilton Medical Inc II Apr-08-2011
67 Hamilton Medical, Inc. I Sep-20-2023
68 Hamilton Medical, Inc. I Jul-21-2023
69 Hamilton Medical, Inc. II Nov-28-2016
70 Hamilton Medical, Inc. II May-09-2016
71 Hamilton Medical, Inc. I Nov-04-2015
72 Hamilton Medical, Inc. II Jul-10-2015
73 Hamilton Medical, Inc. II Nov-06-2013
74 Hill-Rom Manufacturing, Inc. II Nov-24-2020
75 Impact Instrumentation, Inc. III Aug-07-2012
76 Impact Instrumentation, Inc. II Aug-29-2011
77 MAQUET Inc. II Jan-05-2010
78 MAQUET Inc. II May-12-2009
79 MAQUET Inc. II Feb-03-2009
80 Maquet Cardiovascular Us Sales, Llc I Apr-26-2013
81 Maquet Inc. II Apr-03-2012
82 Maquet Inc. II Dec-02-2011
83 Maquet Inc. II Jun-23-2011
84 Medtronic formerly Covidien I Apr-25-2022
85 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
86 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Dec-09-2014
87 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Oct-28-2014
88 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-20-2014
89 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-17-2014
90 Nellcor Puritan Bennett Inc. (dba Covidien LP) II May-09-2014
91 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jan-24-2014
92 Newport Medical Instruments Inc I Apr-10-2017
93 Newport Medical Instruments Inc I Apr-14-2014
94 Newport Medical Instruments Inc I Apr-26-2013
95 Newport Medical Instruments Inc II Jun-08-2011
96 Newport Medical Instruments Inc II Jun-02-2011
97 Newport Medical Instruments Inc II May-27-2011
98 Newport Medical Instruments Inc II May-26-2011
99 Newport Medical Instruments Inc II May-26-2011
100 Newport Medical Instruments Inc II May-19-2010
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