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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 2
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
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 11104
2021 13322 13328
2022 15974 15976
2023 24928 24928
2024 20336 20336
2025 12074 12077

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11608 11608
Output Problem 11566 11567
Circuit Failure 6670 6670
Battery Problem 5590 5590
Electrical /Electronic Property Problem 5408 5408
Failure to Run on Battery 4742 4742
Failure to Recalibrate 4604 4604
No Display/Image 4164 4164
Defective Component 3848 3848
Failure to Calibrate 3096 3096
Failure of Device to Self-Test 3007 3008
Failure to Power Up 2800 2800
Gas/Air Leak 2666 2666
Insufficient Flow or Under Infusion 2613 2613
Display or Visual Feedback Problem 2433 2433
Degraded 2380 2380
Improper Flow or Infusion 2125 2125
Failure to Charge 1918 1918
Unexpected Shutdown 1858 1858
Power Problem 1592 1592
Insufficient Information 1576 1576
Contamination 1544 1544
Protective Measures Problem 1524 1524
Infusion or Flow Problem 1444 1444
No Flow 1255 1255
Failure to Deliver 1215 1215
Decrease in Pressure 1145 1146
Gas Output Problem 1096 1096
Leak/Splash 1024 1028
Pressure Problem 841 841
Device Displays Incorrect Message 746 746
Complete Loss of Power 696 696
Therapeutic or Diagnostic Output Failure 606 608
Adverse Event Without Identified Device or Use Problem 566 566
Calibration Problem 524 524
Computer Software Problem 457 457
Communication or Transmission Problem 406 406
Connection Problem 404 404
Inadequate User Interface 400 400
Device Sensing Problem 399 399
Application Program Problem 398 398
Device Alarm System 390 390
Use of Device Problem 350 350
No Apparent Adverse Event 332 332
Increase in Pressure 330 330
Loose or Intermittent Connection 286 288
Tidal Volume Fluctuations 284 284
Unexpected Therapeutic Results 283 283
False Positive Result 282 282
Fracture 265 265

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83020 83029
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1996 1998
Low Oxygen Saturation 1002 1004
Unspecified Respiratory Problem 565 565
No Information 556 556
Headache 375 375
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
Dizziness 270 270
Dyspnea 259 261
Respiratory Failure 177 177
Asthma 176 176
Cancer 167 167
Cardiac Arrest 147 147
Respiratory Insufficiency 141 141
Unspecified Kidney or Urinary Problem 140 140
Respiratory Tract Infection 129 129
Nausea 126 126
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Death 92 94
Cough 91 91
Hypoxia 89 91
Inflammation 89 89
Ventilator Dependent 83 83
Bradycardia 81 81
Sore Throat 77 77
Hypersensitivity/Allergic reaction 75 75
Unspecified Heart Problem 63 63
Respiratory Arrest 61 61
Pneumothorax 57 57
Pneumonia 55 55
Chronic Obstructive Pulmonary Disease (COPD) 54 54
Cyanosis 40 40
Unspecified Hepatic or Biliary Problem 36 36
Heart Failure/Congestive Heart Failure 31 31
Hypoventilation 29 29
Apnea 29 29
Discomfort 28 28
Increased Respiratory Rate 26 26
Low Blood Pressure/ Hypotension 25 25
Loss of consciousness 22 22
Tachycardia 21 21
Chest Pain 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 Aug-19-2025
23 Hamilton Medical AG I Jun-18-2024
24 Hamilton Medical AG II Apr-25-2023
25 Hamilton Medical AG II Nov-18-2022
26 Hamilton Medical AG I Aug-19-2022
27 Hamilton Medical, Inc. I Sep-20-2023
28 Hamilton Medical, Inc. I Jul-21-2023
29 Hill-Rom Manufacturing, Inc. II Nov-24-2020
30 Maquet Critical Care AB I Jun-27-2025
31 Medtronic formerly Covidien I Apr-25-2022
32 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
33 Percussionaire Corporation I Jan-23-2025
34 Percussionaire Corporation I Jan-17-2024
35 Percussionaire Corporation I Jan-17-2024
36 Percussionaire Corporation II Nov-07-2023
37 Philips Respironics, Inc. I Nov-13-2024
38 Philips Respironics, Inc. I Sep-05-2024
39 Philips Respironics, Inc. I Apr-17-2024
40 Philips Respironics, Inc. II Jan-04-2024
41 Philips Respironics, Inc. II Jul-07-2023
42 Philips Respironics, Inc. I Jun-02-2023
43 Philips Respironics, Inc. I Apr-03-2023
44 Philips Respironics, Inc. I Jan-06-2023
45 Philips Respironics, Inc. I Mar-18-2022
46 Philips Respironics, Inc. I Jan-22-2022
47 Philips Respironics, Inc. II Aug-13-2021
48 Philips Respironics, Inc. I Jul-15-2021
49 Philips Respironics, Inc. I Feb-15-2020
50 ResMed Ltd. I Oct-23-2023
51 Ventec Life Systems, Inc. I Feb-26-2025
52 Ventec Life Systems, Inc. I Feb-23-2024
53 Ventec Life Systems, Inc. II Jun-21-2021
54 Vyaire Medical II Jun-15-2023
55 Vyaire Medical I Feb-16-2022
56 Vyaire Medical II Mar-04-2020
57 ZOLL Medical Corporation I Jun-20-2024
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