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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
  1.  K192604  Servo-air 4.0 Ventilator System
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

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 13701 13701
Output Problem 12161 12165
Circuit Failure 8056 8056
Battery Problem 6210 6244
Electrical /Electronic Property Problem 5874 5874
Failure to Recalibrate 5342 5342
Failure to Run on Battery 4841 4842
No Display/Image 4591 4591
Defective Component 3933 3933
Failure to Calibrate 3694 3960
Failure of Device to Self-Test 3362 3363
Failure to Power Up 3087 3090
Insufficient Flow or Under Infusion 2856 2856
Gas/Air Leak 2758 2759
Display or Visual Feedback Problem 2676 2676
Degraded 2419 2430
Improper Flow or Infusion 2326 2326
Failure to Charge 2321 2337
Unexpected Shutdown 2060 2060
Protective Measures Problem 1846 1885
Power Problem 1753 1796
Insufficient Information 1728 1729
Contamination 1670 1670
Infusion or Flow Problem 1584 1584
No Flow 1512 1512
Failure to Deliver 1424 1425
Decrease in Pressure 1196 1198
Gas Output Problem 1184 1185
Leak/Splash 1085 1089
Pressure Problem 948 948
Device Displays Incorrect Message 942 942
Therapeutic or Diagnostic Output Failure 827 829
Calibration Problem 751 751
Complete Loss of Power 747 747
Adverse Event Without Identified Device or Use Problem 648 649
Application Program Problem 564 564
Incorrect, Inadequate or Imprecise Result or Readings 558 558
Computer Software Problem 523 523
Device Alarm System 515 515
Device Sensing Problem 504 504
Inadequate User Interface 466 470
Communication or Transmission Problem 453 453
Use of Device Problem 429 429
Connection Problem 416 416
No Apparent Adverse Event 374 375
Increase in Pressure 367 367
Tidal Volume Fluctuations 341 341
Loose or Intermittent Connection 302 304
False Positive Result 294 294
Unexpected Therapeutic Results 286 286

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85127 85146
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2043 2046
Low Oxygen Saturation 1138 1141
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 290 290
Dizziness 269 269
Dyspnea 264 272
Death 185 188
Respiratory Failure 183 183
Asthma 178 178
Cancer 166 167
Cardiac Arrest 161 161
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 102 102
Cough 91 91
Inflammation 89 89
Bradycardia 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 35 35
Heart Failure/Congestive Heart Failure 32 32
Discomfort 30 30
Apnea 29 29
Increased Respiratory Rate 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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