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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 14197 14200

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 10936 10940
Mechanical Problem 9697 9697
Circuit Failure 5838 5838
Electrical /Electronic Property Problem 5489 5489
Battery Problem 4841 4841
Failure to Run on Battery 4803 4804
Failure to Recalibrate 3802 3802
No Display/Image 3774 3774
Defective Component 3747 3747
Failure to Calibrate 2971 2971
Insufficient Flow or Under Infusion 2837 2837
Gas/Air Leak 2685 2686
Failure of Device to Self-Test 2655 2656
Failure to Power Up 2499 2502
Degraded 2293 2304
Display or Visual Feedback Problem 2228 2228
Improper Flow or Infusion 2104 2104
Unexpected Shutdown 1710 1710
Contamination 1485 1485
Failure to Charge 1458 1458
Power Problem 1454 1455
Insufficient Information 1424 1424
Infusion or Flow Problem 1292 1292
No Flow 1137 1137
Failure to Deliver 1076 1077
Decrease in Pressure 1047 1049
Protective Measures Problem 966 966
Gas Output Problem 940 941
Leak/Splash 913 913
Pressure Problem 723 723
Complete Loss of Power 645 645
Adverse Event Without Identified Device or Use Problem 537 538
Device Sensing Problem 472 472
Device Displays Incorrect Message 459 459
Computer Software Problem 439 439
Therapeutic or Diagnostic Output Failure 434 436
Calibration Problem 410 410
Connection Problem 403 403
No Apparent Adverse Event 354 355
Communication or Transmission Problem 342 342
Increase in Pressure 334 334
Device Alarm System 314 314
Application Program Problem 304 304
False Positive Result 294 294
Use of Device Problem 286 286
Unexpected Therapeutic Results 283 283
Loose or Intermittent Connection 283 285
Inadequate User Interface 277 277
Fracture 269 271
Charging Problem 228 228

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83050 83065
Insufficient Information 1974 1977
Low Oxygen Saturation 924 925
Unspecified Respiratory Problem 567 571
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 283 283
Dizziness 269 269
Dyspnea 254 262
Asthma 178 178
Respiratory Failure 174 174
Cancer 166 167
Cardiac Arrest 144 144
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 91 93
Cough 91 91
Inflammation 89 89
Ventilator Dependent 83 83
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Bradycardia 69 69
Unspecified Heart Problem 62 62
Respiratory Arrest 59 59
Pneumonia 54 54
Chronic Obstructive Pulmonary Disease (COPD) 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
Apnea 26 26
Increased Respiratory Rate 26 26
Hypoventilation 22 22
Low Blood Pressure/ Hypotension 21 21
Chest Pain 21 21
Death 19 19
Unspecified Eye / Vision Problem 18 18
Loss of consciousness 18 18
Tachycardia 17 17
Pulmonary Dysfunction 17 17
Liver Damage/Dysfunction 14 14
Stroke/CVA 14 14
Respiratory Acidosis 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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