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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
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
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
  1.  K240807  VM-2000
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 12968 12971

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11750 11750
Output Problem 11691 11695
Circuit Failure 6777 6777
Battery Problem 5625 5625
Electrical /Electronic Property Problem 5564 5564
Failure to Run on Battery 4775 4776
Failure to Recalibrate 4634 4634
No Display/Image 4183 4183
Defective Component 3852 3852
Failure to Calibrate 3244 3244
Failure of Device to Self-Test 3081 3082
Failure to Power Up 2825 2828
Insufficient Flow or Under Infusion 2701 2701
Gas/Air Leak 2687 2688
Display or Visual Feedback Problem 2454 2454
Degraded 2382 2393
Improper Flow or Infusion 2178 2178
Failure to Charge 1925 1925
Unexpected Shutdown 1911 1911
Power Problem 1617 1618
Insufficient Information 1598 1599
Contamination 1568 1568
Protective Measures Problem 1525 1525
Infusion or Flow Problem 1454 1454
No Flow 1289 1289
Failure to Deliver 1233 1234
Decrease in Pressure 1154 1156
Gas Output Problem 1111 1112
Leak/Splash 1025 1029
Pressure Problem 856 856
Device Displays Incorrect Message 747 747
Complete Loss of Power 708 708
Therapeutic or Diagnostic Output Failure 606 608
Adverse Event Without Identified Device or Use Problem 577 578
Calibration Problem 525 525
Computer Software Problem 461 461
Device Sensing Problem 419 419
Communication or Transmission Problem 414 414
Connection Problem 407 407
Device Alarm System 403 403
Inadequate User Interface 401 401
Application Program Problem 398 398
Use of Device Problem 356 356
No Apparent Adverse Event 351 352
Increase in Pressure 337 337
False Positive Result 291 291
Loose or Intermittent Connection 287 289
Unexpected Therapeutic Results 285 285
Tidal Volume Fluctuations 284 284
Incorrect, Inadequate or Imprecise Result or Readings 278 278

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83891 83910
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2019 2022
Low Oxygen Saturation 1018 1021
Unspecified Respiratory Problem 569 573
No Information 556 556
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 291 291
No Known Impact Or Consequence To Patient 290 290
Dizziness 270 270
Dyspnea 261 269
Respiratory Failure 179 179
Asthma 178 178
Cancer 167 168
Cardiac Arrest 148 148
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Death 92 95
Hypoxia 91 93
Cough 91 91
Inflammation 89 89
Ventilator Dependent 83 83
Bradycardia 81 81
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Unspecified Heart Problem 64 64
Respiratory Arrest 62 62
Pneumothorax 57 57
Pneumonia 56 56
Chronic Obstructive Pulmonary Disease (COPD) 54 54
Cyanosis 40 40
Unspecified Hepatic or Biliary Problem 36 36
Heart Failure/Congestive Heart Failure 32 32
Hypoventilation 30 30
Apnea 29 29
Discomfort 29 29
Increased Respiratory Rate 26 26
Low Blood Pressure/ Hypotension 25 25
Tachycardia 22 22
Loss of consciousness 22 22
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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