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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
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 3
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 11105
2021 13322 13333
2022 15974 15986
2023 24928 24932
2024 20336 20339
2025 14196 14199
2026 3312 3313

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12522 12522
Output Problem 11914 11918
Circuit Failure 7256 7256
Electrical /Electronic Property Problem 6149 6149
Battery Problem 5778 5778
Failure to Run on Battery 5055 5056
Failure to Recalibrate 4724 4724
No Display/Image 4260 4260
Failure to Calibrate 3959 3959
Defective Component 3861 3861
Failure of Device to Self-Test 3483 3484
Insufficient Flow or Under Infusion 3157 3157
Failure to Power Up 2879 2882
Gas/Air Leak 2737 2738
Degraded 2720 2731
Display or Visual Feedback Problem 2544 2544
Improper Flow or Infusion 2324 2324
Unexpected Shutdown 2012 2013
Failure to Charge 1955 1955
Power Problem 1734 1735
Insufficient Information 1638 1639
Contamination 1635 1635
Protective Measures Problem 1530 1530
Infusion or Flow Problem 1521 1521
No Flow 1370 1370
Failure to Deliver 1315 1316
Gas Output Problem 1201 1202
Decrease in Pressure 1178 1180
Leak/Splash 1032 1036
Pressure Problem 903 903
Device Displays Incorrect Message 747 747
Complete Loss of Power 726 726
Device Sensing Problem 654 654
Therapeutic or Diagnostic Output Failure 636 638
Adverse Event Without Identified Device or Use Problem 601 602
Calibration Problem 559 559
Computer Software Problem 518 518
Device Alarm System 439 439
Communication or Transmission Problem 430 430
Inadequate User Interface 412 412
Connection Problem 410 410
Application Program Problem 399 399
No Apparent Adverse Event 389 390
Use of Device Problem 377 377
Increase in Pressure 349 349
Loose or Intermittent Connection 303 305
False Positive Result 298 298
Tidal Volume Fluctuations 293 293
Unexpected Therapeutic Results 289 289
Fracture 287 289

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88270 88290
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2104 2107
Low Oxygen Saturation 1060 1063
Unspecified Respiratory Problem 569 573
No Information 556 556
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 294 294
No Known Impact Or Consequence To Patient 290 290
Dizziness 269 269
Dyspnea 264 272
Respiratory Failure 181 181
Asthma 178 178
Cancer 167 168
Cardiac Arrest 155 155
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Skin Inflammation/ Irritation 107 107
Hypoxia 105 107
Vomiting 101 101
Death 92 95
Cough 91 91
Inflammation 89 89
Bradycardia 88 88
Ventilator Dependent 83 83
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Unspecified Heart Problem 63 63
Respiratory Arrest 63 63
Pneumonia 58 58
Pneumothorax 57 57
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 42 42
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 34 34
Heart Failure/Congestive Heart Failure 32 32
Discomfort 30 30
Apnea 29 29
Increased Respiratory Rate 27 27
Low Blood Pressure/ Hypotension 25 25
Loss of consciousness 23 23
Tachycardia 22 22
Chest Pain 21 21
Unspecified Eye / Vision Problem 18 18
Respiratory Acidosis 17 17
Pulmonary Dysfunction 17 17
Stroke/CVA 15 15

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 Apr-02-2026
38 Philips Respironics, Inc. I Mar-26-2026
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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