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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
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 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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
Output Problem 11021 11025
Mechanical Problem 10055 10055
Circuit Failure 6036 6036
Electrical /Electronic Property Problem 5718 5718
Failure to Run on Battery 4971 4972
Battery Problem 4905 4905
Failure to Recalibrate 3855 3855
No Display/Image 3813 3813
Defective Component 3752 3752
Failure to Calibrate 3241 3241
Insufficient Flow or Under Infusion 3019 3019
Failure of Device to Self-Test 2858 2859
Gas/Air Leak 2702 2703
Failure to Power Up 2525 2528
Degraded 2332 2343
Display or Visual Feedback Problem 2257 2257
Improper Flow or Infusion 2174 2174
Unexpected Shutdown 1756 1756
Contamination 1519 1519
Power Problem 1500 1501
Failure to Charge 1473 1473
Insufficient Information 1438 1438
Infusion or Flow Problem 1323 1323
No Flow 1177 1177
Failure to Deliver 1099 1100
Decrease in Pressure 1058 1060
Gas Output Problem 983 984
Protective Measures Problem 967 967
Leak/Splash 915 915
Pressure Problem 744 744
Complete Loss of Power 653 653
Device Sensing Problem 561 561
Adverse Event Without Identified Device or Use Problem 547 548
Device Displays Incorrect Message 459 459
Computer Software Problem 457 457
Therapeutic or Diagnostic Output Failure 452 454
Calibration Problem 419 419
Connection Problem 405 405
No Apparent Adverse Event 372 373
Communication or Transmission Problem 346 346
Increase in Pressure 340 340
Device Alarm System 331 331
Application Program Problem 305 305
Use of Device Problem 297 297
False Positive Result 296 296
Loose or Intermittent Connection 294 296
Unexpected Therapeutic Results 286 286
Inadequate User Interface 282 282
Fracture 278 280
Charging Problem 237 237

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 84874 84889
Insufficient Information 2013 2016
Low Oxygen Saturation 942 943
Unspecified Respiratory Problem 568 572
No Consequences Or Impact To Patient 534 534
Headache 374 377
No Patient Involvement 306 307
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 285 285
Dizziness 269 269
Dyspnea 256 264
Asthma 178 178
Respiratory Failure 175 175
Cancer 167 168
Cardiac Arrest 146 146
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
Hypoxia 94 96
Cough 91 91
Inflammation 89 89
Ventilator Dependent 83 83
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Bradycardia 74 74
Unspecified Heart Problem 62 62
Respiratory Arrest 59 59
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Pneumonia 54 54
Pneumothorax 47 47
No Information 40 40
Unspecified Hepatic or Biliary Problem 36 36
Cyanosis 33 33
Heart Failure/Congestive Heart Failure 32 32
Discomfort 30 30
Increased Respiratory Rate 27 27
Apnea 26 26
Hypoventilation 23 23
Low Blood Pressure/ Hypotension 21 21
Chest Pain 21 21
Death 19 19
Loss of consciousness 18 18
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
Tachycardia 17 17
Stroke/CVA 15 15
Liver Damage/Dysfunction 14 14
Bronchitis 13 13

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 Draeger Medical, Inc. I Aug-18-2023
11 Draeger Medical, Inc. I Jul-08-2023
12 Draeger Medical, Inc. I Feb-24-2023
13 Draeger Medical, Inc. II Apr-04-2022
14 Draeger Medical, Inc. II Oct-14-2021
15 Draeger Medical, Inc. II May-28-2021
16 GE Healthcare, LLC I Jun-06-2022
17 Getinge Usa Sales Inc II Aug-24-2022
18 Getinge Usa Sales Inc I Aug-22-2022
19 Hamilton Medical AG I Aug-19-2025
20 Hamilton Medical AG I Jun-18-2024
21 Hamilton Medical AG II Apr-25-2023
22 Hamilton Medical AG II Nov-18-2022
23 Hamilton Medical AG I Aug-19-2022
24 Hamilton Medical, Inc. I Sep-20-2023
25 Hamilton Medical, Inc. I Jul-21-2023
26 Maquet Critical Care AB I Jun-27-2025
27 Medtronic formerly Covidien I Apr-25-2022
28 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
29 Percussionaire Corporation I Jan-23-2025
30 Percussionaire Corporation I Jan-17-2024
31 Percussionaire Corporation I Jan-17-2024
32 Percussionaire Corporation II Nov-07-2023
33 Philips Respironics, Inc. I Nov-13-2024
34 Philips Respironics, Inc. I Sep-05-2024
35 Philips Respironics, Inc. I Apr-17-2024
36 Philips Respironics, Inc. II Jan-04-2024
37 Philips Respironics, Inc. II Jul-07-2023
38 Philips Respironics, Inc. I Jun-02-2023
39 Philips Respironics, Inc. I Apr-03-2023
40 Philips Respironics, Inc. I Jan-06-2023
41 Philips Respironics, Inc. I Mar-18-2022
42 Philips Respironics, Inc. I Jan-22-2022
43 Philips Respironics, Inc. II Aug-13-2021
44 Philips Respironics, Inc. I Jul-15-2021
45 ResMed Ltd. I Oct-23-2023
46 Ventec Life Systems, Inc. I Feb-26-2025
47 Ventec Life Systems, Inc. I Feb-23-2024
48 Ventec Life Systems, Inc. II Jun-21-2021
49 Vyaire Medical II Jun-15-2023
50 Vyaire Medical I Feb-16-2022
51 ZOLL Medical Corporation I Jun-20-2024
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