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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
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 14197 14200
2026 923 923

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 13877 13877
Output Problem 12194 12198
Circuit Failure 8177 8177
Battery Problem 6236 6270
Electrical /Electronic Property Problem 5986 5986
Failure to Recalibrate 5380 5380
Failure to Run on Battery 4969 4970
No Display/Image 4610 4610
Defective Component 3936 3936
Failure to Calibrate 3824 4090
Failure of Device to Self-Test 3449 3450
Failure to Power Up 3102 3105
Insufficient Flow or Under Infusion 2928 2928
Gas/Air Leak 2763 2764
Display or Visual Feedback Problem 2689 2689
Degraded 2422 2433
Improper Flow or Infusion 2354 2354
Failure to Charge 2325 2341
Unexpected Shutdown 2081 2081
Protective Measures Problem 1847 1886
Power Problem 1770 1813
Insufficient Information 1735 1736
Contamination 1681 1681
Infusion or Flow Problem 1601 1601
No Flow 1530 1530
Failure to Deliver 1434 1435
Gas Output Problem 1204 1205
Decrease in Pressure 1199 1201
Leak/Splash 1087 1091
Pressure Problem 961 961
Device Displays Incorrect Message 942 942
Therapeutic or Diagnostic Output Failure 837 839
Calibration Problem 757 757
Complete Loss of Power 752 752
Adverse Event Without Identified Device or Use Problem 654 655
Application Program Problem 564 564
Incorrect, Inadequate or Imprecise Result or Readings 559 559
Device Sensing Problem 544 544
Computer Software Problem 531 531
Device Alarm System 523 523
Inadequate User Interface 470 474
Communication or Transmission Problem 456 456
Use of Device Problem 433 433
Connection Problem 417 417
No Apparent Adverse Event 384 385
Increase in Pressure 369 369
Tidal Volume Fluctuations 342 342
Loose or Intermittent Connection 309 311
False Positive Result 294 294
Unexpected Therapeutic Results 288 288

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86013 86032
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2065 2068
Low Oxygen Saturation 1143 1146
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 568 572
Headache 374 377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 291 291
Dizziness 269 269
Dyspnea 264 272
Death 185 188
Respiratory Failure 183 183
Asthma 178 178
Cancer 167 168
Cardiac Arrest 162 162
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 106 108
Vomiting 102 102
Cough 91 91
Bradycardia 90 90
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) 54 54
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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