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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 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 3
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231778  Nihon Kohden NKV-550 Series Ventilator System
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20336 20336
2025 7937 7937

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 11215 11215
Mechanical Problem 11113 11113
Circuit Failure 6216 6216
Battery Problem 5476 5476
Electrical /Electronic Property Problem 4895 4895
Failure to Run on Battery 4563 4563
Failure to Recalibrate 4273 4273
No Display/Image 4079 4079
Defective Component 3840 3840
Failure to Power Up 2726 2726
Failure of Device to Self-Test 2657 2657
Gas/Air Leak 2611 2611
Failure to Calibrate 2571 2571
Display or Visual Feedback Problem 2365 2365
Degraded 2316 2316
Insufficient Flow or Under Infusion 2219 2219
Improper Flow or Infusion 1950 1950
Failure to Charge 1883 1883
Unexpected Shutdown 1722 1722
Insufficient Information 1529 1529
Protective Measures Problem 1521 1521
Contamination 1473 1473
Power Problem 1443 1443
Infusion or Flow Problem 1349 1349
No Flow 1152 1152
Failure to Deliver 1145 1145
Decrease in Pressure 1106 1106
Gas Output Problem 1021 1021
Leak/Splash 1020 1020
Pressure Problem 813 813
Device Displays Incorrect Message 746 746
Complete Loss of Power 679 679
Therapeutic or Diagnostic Output Failure 585 585
Adverse Event Without Identified Device or Use Problem 543 543
Calibration Problem 505 505
Computer Software Problem 442 442
Connection Problem 400 400
Application Program Problem 396 396
Inadequate User Interface 394 394
Communication or Transmission Problem 386 386
Device Alarm System 361 361
Use of Device Problem 328 328
Increase in Pressure 314 314
No Apparent Adverse Event 279 279
Device Sensing Problem 279 279
False Positive Result 277 277
Tidal Volume Fluctuations 275 275
Loose or Intermittent Connection 272 272
Unexpected Therapeutic Results 269 269
Fracture 256 256

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79059 79059
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1937 1937
Low Oxygen Saturation 961 961
No Information 556 556
Unspecified Respiratory Problem 545 545
Headache 360 360
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 279 279
Dizziness 259 259
Dyspnea 252 252
Respiratory Failure 170 170
Asthma 168 168
Cancer 160 160
Cardiac Arrest 144 144
Respiratory Insufficiency 141 141
Unspecified Kidney or Urinary Problem 133 133
Respiratory Tract Infection 128 128
Nausea 117 117
Skin Inflammation/ Irritation 100 100
Vomiting 93 93
Death 91 91
Cough 90 90
Inflammation 85 85
Ventilator Dependent 83 83
Hypoxia 81 81
Sore Throat 77 77
Bradycardia 75 75
Hypersensitivity/Allergic reaction 73 73
Respiratory Arrest 62 62
Unspecified Heart Problem 59 59
Pneumothorax 54 54
Pneumonia 52 52
Chronic Obstructive Pulmonary Disease (COPD) 47 47
Cyanosis 37 37
Unspecified Hepatic or Biliary Problem 35 35
Discomfort 30 30
Hypoventilation 29 29
Heart Failure/Congestive Heart Failure 28 28
Apnea 27 27
Low Blood Pressure/ Hypotension 25 25
Increased Respiratory Rate 23 23
Loss of consciousness 22 22
Chest Pain 21 21
Tachycardia 21 21
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
Respiratory Acidosis 15 15
Liver Damage/Dysfunction 14 14

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 Getinge Group Logistics America, LLC II Oct-09-2020
20 Getinge Usa Sales Inc II Aug-24-2022
21 Getinge Usa Sales Inc I Aug-22-2022
22 Hamilton Medical AG I Jun-18-2024
23 Hamilton Medical AG II Apr-25-2023
24 Hamilton Medical AG II Nov-18-2022
25 Hamilton Medical AG I Aug-19-2022
26 Hamilton Medical, Inc. I Sep-20-2023
27 Hamilton Medical, Inc. I Jul-21-2023
28 Hill-Rom Manufacturing, Inc. II Nov-24-2020
29 Maquet Critical Care AB I Jun-27-2025
30 Medtronic formerly Covidien I Apr-25-2022
31 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
32 Percussionaire Corporation I Jan-23-2025
33 Percussionaire Corporation I Jan-17-2024
34 Percussionaire Corporation I Jan-17-2024
35 Percussionaire Corporation II Nov-07-2023
36 Philips Respironics, Inc. I Nov-13-2024
37 Philips Respironics, Inc. I Sep-05-2024
38 Philips Respironics, Inc. I Apr-17-2024
39 Philips Respironics, Inc. II Jan-04-2024
40 Philips Respironics, Inc. II Jul-07-2023
41 Philips Respironics, Inc. I Jun-02-2023
42 Philips Respironics, Inc. I Apr-03-2023
43 Philips Respironics, Inc. I Jan-06-2023
44 Philips Respironics, Inc. I Mar-18-2022
45 Philips Respironics, Inc. I Jan-22-2022
46 Philips Respironics, Inc. II Aug-13-2021
47 Philips Respironics, Inc. I Jul-15-2021
48 Philips Respironics, Inc. I Feb-15-2020
49 ResMed Ltd. I Oct-23-2023
50 Ventec Life Systems, Inc. I Feb-26-2025
51 Ventec Life Systems, Inc. I Feb-23-2024
52 Ventec Life Systems, Inc. II Jun-21-2021
53 Vyaire Medical II Jun-15-2023
54 Vyaire Medical I Feb-16-2022
55 Vyaire Medical II Mar-04-2020
56 ZOLL Medical Corporation I Jun-20-2024
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