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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
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
OCONNELL REGULATORY CONSULTANTS, INC.
  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 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECME S.A.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K101401  NEUMOVENT GRAPHNET MODEL 3179L1V
  2.  K111595  NEUMOVENT GRAPHNET
VENTEC LIFE SYSTEMS, 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 24956 24956
2024 9622 9622

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 15343 15343
Mechanical Problem 12662 12662
Device Operates Differently Than Expected 9862 9862
Output Problem 9801 9801
No Display/Image 8466 8466
Circuit Failure 7208 7208
Battery Problem 6446 6480
Device Inoperable 6042 6042
Failure to Recalibrate 4876 4876
Failure to Charge 4595 4611
Failure to Run on Battery 3980 3980
Defective Component 3913 3913
Failure to Calibrate 3894 4160
Failure to Power Up 3729 3729
Electrical /Electronic Property Problem 3552 3552
Incorrect Or Inadequate Test Results 2611 2611
Display or Visual Feedback Problem 2540 2540
Failure of Device to Self-Test 2371 2371
Device Operational Issue 2347 2347
Gas/Air Leak 2173 2173
Appropriate Term/Code Not Available 2089 2089
Protective Measures Problem 2061 2100
Improper Flow or Infusion 1910 1910
Degraded 1890 1890
Power Problem 1844 1886
Leak/Splash 1564 1564
Insufficient Information 1556 1556
No Flow 1464 1464
Failure to Deliver 1444 1444
Contamination 1438 1438
Device Alarm System 1432 1432
Unexpected Shutdown 1368 1368
Infusion or Flow Problem 1340 1340
Pressure Problem 1195 1195
Adverse Event Without Identified Device or Use Problem 1165 1165
Erratic or Intermittent Display 1162 1162
Loss of Power 1158 1158
Calibration Problem 1135 1135
Decrease in Pressure 1087 1087
Insufficient Flow or Under Infusion 973 973
Gas Output Problem 878 878
Break 861 861
Communication or Transmission Problem 835 835
Tidal Volume Fluctuations 729 729
Therapeutic or Diagnostic Output Failure 702 702
Inaccurate Delivery 699 699
Charging Problem 677 677
Noise, Audible 632 632
Application Program Problem 618 618
Failure to Cycle 599 599
Incorrect, Inadequate or Imprecise Result or Readings 568 568
Complete Loss of Power 566 566
Device Stops Intermittently 514 514
Connection Problem 492 492
Computer Software Problem 488 488
No Audible Alarm 466 466
Inadequate User Interface 456 460
Thermal Decomposition of Device 452 452
Use of Device Problem 421 421
Application Interface Becomes Non-Functional Or Program Exits Abnormally 405 405
Increase in Pressure 398 398
Inappropriate or Unexpected Reset 372 373
Self-Activation or Keying 347 347
Device Sensing Problem 342 342
Volume Accuracy Problem 341 341
Image Display Error/Artifact 327 327
Defective Device 320 320
Disconnection 312 312
Reset Problem 302 302
Premature Discharge of Battery 300 300
Computer Operating System Problem 294 294
Loose or Intermittent Connection 285 285
Smoking 284 284
Excess Flow or Over-Infusion 259 259
Defective Alarm 259 259
Device Maintenance Issue 248 248
Occlusion Within Device 247 247
Temperature Problem 243 243
Alarm Not Visible 219 219
Poor Quality Image 217 217
Contamination /Decontamination Problem 215 215
Peeled/Delaminated 214 214
Aborted Charge 213 213
False Positive Result 208 208
Medical Gas Supply Problem 199 199
Obstruction of Flow 198 198
Low Readings 191 191
No Pressure 187 187
Device Emits Odor 179 179
Detachment of Device or Device Component 175 175
Ventilation Problem in Device Environment 174 174
Fracture 168 168
Overheating of Device 165 165
Suction Problem 165 165
Unexpected Therapeutic Results 161 161
Failure to Conduct 159 159
Crack 151 151
Mechanical Jam 147 147
Operating System Becomes Nonfunctional 145 145
Key or Button Unresponsive/not Working 140 140

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61364 61364
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 1701 1701
Low Oxygen Saturation 1318 1319
No Code Available 1161 1161
Death 725 725
Unspecified Respiratory Problem 359 359
Dyspnea 273 273
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 261 261
Headache 253 253
Cardiac Arrest 190 190
Respiratory Failure 175 175
Dizziness 158 158
Respiratory Insufficiency 124 124
Respiratory Distress 120 120
Respiratory Tract Infection 110 110
Hypoxia 109 109
Bradycardia 106 106
Cancer 92 92
Asthma 90 90
Cough 85 85
Ventilator Dependent 82 82
Unspecified Kidney or Urinary Problem 81 81
Cyanosis 80 80
Sore Throat 76 76
Pneumothorax 73 73
Nausea 71 71
Skin Inflammation/ Irritation 60 60
Hypoventilation 56 56
Vomiting 55 55
Pneumonia 53 53
Patient Problem/Medical Problem 52 52
Low Blood Pressure/ Hypotension 46 46
Hypersensitivity/Allergic reaction 45 45
Respiratory Arrest 45 45
Inflammation 44 44
Apnea 41 41
Loss of consciousness 41 41
Injury 40 40
Cardiopulmonary Arrest 40 40
Chronic Obstructive Pulmonary Disease (COPD) 38 38
Increased Respiratory Rate 34 34
Discomfort 33 33
Unspecified Heart Problem 30 30
Tachycardia 30 30
Unspecified Hepatic or Biliary Problem 23 23
Respiratory Acidosis 23 23
Chest Pain 22 22
Heart Failure/Congestive Heart Failure 19 19
Abnormal Blood Gases 17 17
Unspecified Infection 17 17
Pulmonary Dysfunction 16 16
Unspecified Eye / Vision Problem 16 16
Burn(s) 15 15
Stroke/CVA 14 14
High Blood Pressure/ Hypertension 14 14
Hyperventilation 14 14
Anxiety 14 14
Complaint, Ill-Defined 13 13
Epistaxis 11 11
Liver Damage/Dysfunction 11 11
Pain 11 11
Urinary Retention 11 11
Fatigue 10 10
Stacking Breaths 10 10
Nodule 10 10
Decreased Respiratory Rate 10 10
Bowel Perforation 10 10
Distress 9 9
Extubate 9 9
Renal Failure 9 9
Brain Injury 8 8
Dry Eye(s) 8 8
Coma 8 8
Swelling/ Edema 8 8
Overinflation of Lung 7 7
Electric Shock 7 7
Lethargy 7 7
Hemorrhage/Bleeding 7 7
Airway Obstruction 7 7
Bronchitis 7 7
Aspiration/Inhalation 7 7
Burning Sensation 7 7
Rash 7 7
Perforation 7 7
Myocardial Infarction 6 6
Bacterial Infection 6 6
Atrial Fibrillation 6 6
Pulmonary Emphysema 6 6
Encephalopathy 6 6
Fall 6 6
Fever 6 6
Chemical Exposure 6 6
Sleep Dysfunction 6 6
Cognitive Changes 6 6
Confusion/ Disorientation 6 6
Foreign Body In Patient 6 6

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