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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
CORVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMAR S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 2
DRAGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231778  Nihon Kohden NKV-550 Series Ventilator System
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9100 9505
2020 11096 11105
2021 13322 13333
2022 15974 15986
2023 24928 24932
2024 20336 20339
2025 14196 14199
2026 1900 1900

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 14059 14059
Output Problem 12246 12250
Circuit Failure 8254 8254
Battery Problem 6274 6308
Electrical /Electronic Property Problem 6103 6103
Failure to Recalibrate 5395 5395
Failure to Run on Battery 5009 5010
No Display/Image 4630 4630
Failure to Calibrate 3964 4230
Defective Component 3938 3938
Failure of Device to Self-Test 3565 3566
Failure to Power Up 3113 3116
Insufficient Flow or Under Infusion 3038 3038
Gas/Air Leak 2775 2776
Display or Visual Feedback Problem 2705 2705
Degraded 2458 2469
Improper Flow or Infusion 2396 2396
Failure to Charge 2336 2352
Unexpected Shutdown 2106 2106
Protective Measures Problem 1847 1886
Power Problem 1799 1842
Insufficient Information 1742 1743
Contamination 1704 1704
Infusion or Flow Problem 1615 1615
No Flow 1552 1552
Failure to Deliver 1447 1448
Gas Output Problem 1227 1228
Decrease in Pressure 1207 1209
Leak/Splash 1087 1091
Pressure Problem 969 969
Device Displays Incorrect Message 942 942
Therapeutic or Diagnostic Output Failure 845 847
Calibration Problem 760 760
Complete Loss of Power 755 755
Adverse Event Without Identified Device or Use Problem 658 659
Device Sensing Problem 593 593
Application Program Problem 565 565
Incorrect, Inadequate or Imprecise Result or Readings 559 559
Computer Software Problem 541 541
Device Alarm System 532 532
Inadequate User Interface 471 475
Communication or Transmission Problem 457 457
Use of Device Problem 440 440
Connection Problem 418 418
No Apparent Adverse Event 392 393
Increase in Pressure 373 373
Tidal Volume Fluctuations 347 347
Loose or Intermittent Connection 313 315
False Positive Result 296 296
Unexpected Therapeutic Results 289 289

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86951 86970
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2082 2085
Low Oxygen Saturation 1156 1159
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 569 573
Headache 374 377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 292 292
Dizziness 269 269
Dyspnea 266 274
Death 185 188
Respiratory Failure 184 184
Asthma 178 178
Cancer 167 168
Cardiac Arrest 163 163
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 108 110
Skin Inflammation/ Irritation 107 107
Vomiting 102 102
Bradycardia 94 94
Cough 91 91
Inflammation 89 89
Ventilator Dependent 84 84
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Pneumothorax 66 66
No Code Available 66 66
Unspecified Heart Problem 63 63
Respiratory Arrest 62 62
Pneumonia 57 57
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 47 47
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 36 36
Heart Failure/Congestive Heart Failure 32 32
Discomfort 30 30
Increased Respiratory Rate 30 30
Apnea 29 29
Low Blood Pressure/ Hypotension 28 28
Tachycardia 25 25
Loss of consciousness 24 24
Chest Pain 21 21
Respiratory Distress 20 20
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I May-09-2025
2 Baxter Healthcare Corporation I Jan-16-2025
3 Baxter Healthcare Corporation I Oct-22-2024
4 Baxter Healthcare Corporation I Jun-26-2024
5 Baxter Healthcare Corporation I Feb-24-2023
6 Breas Medical, Inc. II Apr-15-2022
7 Covidien I Jun-09-2025
8 Covidien I Aug-02-2024
9 Covidien Llc I Dec-09-2021
10 Covidien Llc II Nov-06-2020
11 Draeger Medical, Inc. I Aug-18-2023
12 Draeger Medical, Inc. I Jul-08-2023
13 Draeger Medical, Inc. I Feb-24-2023
14 Draeger Medical, Inc. II Apr-04-2022
15 Draeger Medical, Inc. II Oct-14-2021
16 Draeger Medical, Inc. II May-28-2021
17 GE Healthcare, LLC I Jun-06-2022
18 GE Healthcare, LLC II Aug-24-2020
19 GE Healthcare, LLC II Dec-17-2019
20 Getinge Group Logistics America, LLC II Oct-09-2020
21 Getinge Usa Sales Inc II Aug-24-2022
22 Getinge Usa Sales Inc I Aug-22-2022
23 Hamilton Medical AG I Aug-19-2025
24 Hamilton Medical AG I Jun-18-2024
25 Hamilton Medical AG II Apr-25-2023
26 Hamilton Medical AG II Nov-18-2022
27 Hamilton Medical AG I Aug-19-2022
28 Hamilton Medical AG I Jul-11-2019
29 Hamilton Medical, Inc. I Sep-20-2023
30 Hamilton Medical, Inc. I Jul-21-2023
31 Hill-Rom Manufacturing, Inc. II Nov-24-2020
32 Maquet Critical Care AB I Jun-27-2025
33 Medtronic formerly Covidien I Apr-25-2022
34 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
35 Percussionaire Corporation I Jan-23-2025
36 Percussionaire Corporation I Jan-17-2024
37 Percussionaire Corporation I Jan-17-2024
38 Percussionaire Corporation II Nov-07-2023
39 Philips Respironics, Inc. I Nov-13-2024
40 Philips Respironics, Inc. I Sep-05-2024
41 Philips Respironics, Inc. I Apr-17-2024
42 Philips Respironics, Inc. II Jan-04-2024
43 Philips Respironics, Inc. II Jul-07-2023
44 Philips Respironics, Inc. I Jun-02-2023
45 Philips Respironics, Inc. I Apr-03-2023
46 Philips Respironics, Inc. I Jan-06-2023
47 Philips Respironics, Inc. I Mar-18-2022
48 Philips Respironics, Inc. I Jan-22-2022
49 Philips Respironics, Inc. II Aug-13-2021
50 Philips Respironics, Inc. I Jul-15-2021
51 Philips Respironics, Inc. I Feb-15-2020
52 ResMed Ltd. I Oct-23-2023
53 Ventec Life Systems, Inc. I Feb-26-2025
54 Ventec Life Systems, Inc. I Feb-23-2024
55 Ventec Life Systems, Inc. II Jun-21-2021
56 Vyaire Medical II Jun-15-2023
57 Vyaire Medical I Feb-16-2022
58 Vyaire Medical II Mar-04-2020
59 ZOLL Medical Corporation I Jun-20-2024
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