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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
  1.  K193228  Hamilton-G5
  2.  K201306  HAMILTON-C3
  3.  K201658  Hamilton-C6
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
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 1900 1900

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12363 12363
Output Problem 11825 11829
Circuit Failure 7133 7133
Electrical /Electronic Property Problem 5989 5989
Battery Problem 5728 5728
Failure to Run on Battery 4998 4999
Failure to Recalibrate 4698 4698
No Display/Image 4234 4234
Defective Component 3861 3861
Failure to Calibrate 3767 3767
Failure of Device to Self-Test 3409 3410
Insufficient Flow or Under Infusion 3026 3026
Failure to Power Up 2865 2868
Gas/Air Leak 2724 2725
Display or Visual Feedback Problem 2510 2510
Degraded 2423 2434
Improper Flow or Infusion 2296 2296
Unexpected Shutdown 1982 1982
Failure to Charge 1950 1950
Power Problem 1695 1696
Insufficient Information 1626 1627
Contamination 1619 1619
Protective Measures Problem 1528 1528
Infusion or Flow Problem 1505 1505
No Flow 1349 1349
Failure to Deliver 1296 1297
Decrease in Pressure 1174 1176
Gas Output Problem 1174 1175
Leak/Splash 1029 1033
Pressure Problem 891 891
Device Displays Incorrect Message 747 747
Complete Loss of Power 723 723
Therapeutic or Diagnostic Output Failure 627 629
Adverse Event Without Identified Device or Use Problem 593 594
Device Sensing Problem 581 581
Calibration Problem 535 535
Computer Software Problem 480 480
Device Alarm System 429 429
Communication or Transmission Problem 421 421
Inadequate User Interface 410 410
Connection Problem 409 409
Application Program Problem 399 399
No Apparent Adverse Event 381 382
Use of Device Problem 373 373
Increase in Pressure 346 346
Loose or Intermittent Connection 300 302
False Positive Result 296 296
Tidal Volume Fluctuations 292 292
Unexpected Therapeutic Results 289 289
Fracture 282 284

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86905 86924
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2080 2083
Low Oxygen Saturation 1047 1050
Unspecified Respiratory Problem 569 573
No Information 556 556
Headache 374 377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 292 292
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 154 154
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 101 103
Vomiting 101 101
Death 92 95
Cough 91 91
Inflammation 89 89
Bradycardia 86 86
Ventilator Dependent 83 83
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Unspecified Heart Problem 63 63
Respiratory Arrest 62 62
Pneumonia 57 57
Pneumothorax 57 57
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 41 41
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 33 33
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 22 22
Tachycardia 22 22
Chest Pain 21 21
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
Respiratory Acidosis 16 16
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 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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