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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 3
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 3
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICONIC SOLUTIONS BY MURCIA, SL
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202970  Ventway Sparrow
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 6311 6312

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12802 12802
Output Problem 12078 12082
Circuit Failure 7504 7504
Electrical /Electronic Property Problem 6528 6528
Battery Problem 5890 5890
Failure to Run on Battery 5224 5225
Failure to Recalibrate 4941 4941
Failure to Calibrate 4358 4358
No Display/Image 4301 4301
Defective Component 3861 3861
Failure of Device to Self-Test 3629 3630
Insufficient Flow or Under Infusion 3357 3357
Failure to Power Up 2992 2995
Gas/Air Leak 2759 2760
Degraded 2745 2756
Display or Visual Feedback Problem 2611 2611
Improper Flow or Infusion 2376 2376
Unexpected Shutdown 2081 2082
Failure to Charge 1960 1960
Power Problem 1797 1798
Insufficient Information 1659 1660
Contamination 1652 1652
Infusion or Flow Problem 1554 1554
Protective Measures Problem 1531 1531
No Flow 1414 1414
Failure to Deliver 1352 1353
Gas Output Problem 1247 1248
Decrease in Pressure 1190 1192
Leak/Splash 1035 1039
Device Sensing Problem 1004 1004
Pressure Problem 914 914
Calibration Problem 802 802
Device Displays Incorrect Message 747 747
Complete Loss of Power 732 732
Computer Software Problem 654 654
Therapeutic or Diagnostic Output Failure 651 653
Adverse Event Without Identified Device or Use Problem 629 630
Device Alarm System 457 457
Communication or Transmission Problem 436 436
Inadequate User Interface 418 418
Connection Problem 410 410
No Apparent Adverse Event 403 404
Application Program Problem 400 400
Use of Device Problem 387 387
Increase in Pressure 354 354
Loose or Intermittent Connection 306 308
False Positive Result 299 299
Tidal Volume Fluctuations 298 298
Fracture 294 296
Unexpected Therapeutic Results 294 294

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91166 91186
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2147 2150
Low Oxygen Saturation 1095 1098
Unspecified Respiratory Problem 570 574
No Information 556 556
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 298 298
No Known Impact Or Consequence To Patient 290 290
Dizziness 269 269
Dyspnea 266 274
Respiratory Failure 181 181
Asthma 178 178
Cancer 167 168
Cardiac Arrest 161 161
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 109 111
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Death 92 95
Cough 91 91
Bradycardia 90 90
Inflammation 89 89
Ventilator Dependent 87 87
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 65 65
Unspecified Heart Problem 63 63
Pneumonia 58 58
Pneumothorax 57 57
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 46 46
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 34 34
Heart Failure/Congestive Heart Failure 32 32
Discomfort 31 31
Apnea 30 30
Increased Respiratory Rate 30 30
Low Blood Pressure/ Hypotension 27 27
Loss of consciousness 25 25
Tachycardia 24 24
Chest Pain 21 21
Respiratory Acidosis 19 19
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
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 Apr-02-2026
38 Philips Respironics, Inc. I Mar-26-2026
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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