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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
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
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICONIC SOLUTIONS BY MURCIA, SL
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
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
  1.  K220107  Mindray SV600 Ventilator, Mindray SV800 Ventilator
  2.  K243767  SV600, SV800 Ventilator
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 14196 14199
2026 7519 7520

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 14616 14616
Output Problem 12389 12393
Circuit Failure 8767 8767
Electrical /Electronic Property Problem 6868 6868
Battery Problem 5761 5795
Failure to Recalibrate 5637 5637
Failure to Run on Battery 5312 5313
Failure to Calibrate 4710 4976
No Display/Image 4507 4507
Defective Component 3705 3705
Insufficient Flow or Under Infusion 3451 3451
Failure to Power Up 3004 3007
Failure of Device to Self-Test 2907 2908
Gas/Air Leak 2774 2775
Degraded 2712 2723
Improper Flow or Infusion 2483 2483
Display or Visual Feedback Problem 2256 2256
Failure to Charge 2217 2233
Unexpected Shutdown 2140 2141
Power Problem 1820 1863
Insufficient Device Problem Information 1770 1771
Contamination 1748 1748
Infusion or Flow Problem 1659 1659
No Flow 1619 1619
Failure to Deliver 1490 1491
Gas Output Problem 1305 1306
Protective Measures Problem 1297 1336
Decrease in Pressure 1222 1224
Device Sensing Problem 1089 1089
Leak/Splash 1042 1042
Calibration Problem 1040 1040
Pressure Problem 945 945
Complete Loss of Power 765 765
Computer Software Problem 713 713
Adverse Event Without Identified Device or Use Problem 679 680
Application Program Problem 561 561
Therapeutic or Diagnostic Output Failure 504 504
Communication or Transmission Problem 453 453
Use of Device Problem 449 449
No Apparent Adverse Event 424 425
Inadequate User Interface 406 410
Connection Problem 404 404
Increase in Pressure 367 367
Device Alarm System 334 334
Loose or Intermittent Connection 303 303
Fracture 302 304
False Positive Result 299 299
Unexpected Therapeutic Results 292 292
Tidal Volume Fluctuations 284 284
Obstruction of Flow 267 267

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92369 92389
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2172 2175
Low Oxygen Saturation 1223 1226
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 570 574
Headache 375 378
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 300 300
Dizziness 269 269
Dyspnea 269 277
Death 185 188
Respiratory Failure 184 184
Asthma 178 178
Cardiac Arrest 174 174
Cancer 167 168
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Eye Irritation 139 139
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 124 126
Skin Inflammation/ Irritation 107 107
Vomiting 102 102
Bradycardia 99 99
Cough 91 91
Inflammation 89 89
Ventilator Dependent 88 88
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 67 67
Pneumothorax 67 67
No Code Available 66 66
Unspecified Heart Problem 63 63
Pneumonia 58 58
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 53 53
Hypoventilation 37 37
Unspecified Hepatic or Biliary Problem 36 36
Increased Respiratory Rate 33 33
Heart Failure/Congestive Heart Failure 33 33
Low Blood Pressure/ Hypotension 32 32
Discomfort 31 31
Apnea 31 31
Tachycardia 28 28
Loss of consciousness 27 27
Chest Pain 21 21
Respiratory Distress 20 20
Respiratory Acidosis 20 20

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 Apr-02-2026
40 Philips Respironics, Inc. I Mar-26-2026
41 Philips Respironics, Inc. I Nov-13-2024
42 Philips Respironics, Inc. I Sep-05-2024
43 Philips Respironics, Inc. I Apr-17-2024
44 Philips Respironics, Inc. II Jan-04-2024
45 Philips Respironics, Inc. II Jul-07-2023
46 Philips Respironics, Inc. I Jun-02-2023
47 Philips Respironics, Inc. I Apr-03-2023
48 Philips Respironics, Inc. I Jan-06-2023
49 Philips Respironics, Inc. I Mar-18-2022
50 Philips Respironics, Inc. I Jan-22-2022
51 Philips Respironics, Inc. II Aug-13-2021
52 Philips Respironics, Inc. I Jul-15-2021
53 Philips Respironics, Inc. I Feb-15-2020
54 ResMed Ltd. I Oct-23-2023
55 Ventec Life Systems, Inc. II Jun-23-2026
56 Ventec Life Systems, Inc. I Feb-26-2025
57 Ventec Life Systems, Inc. I Feb-23-2024
58 Ventec Life Systems, Inc. II Jun-21-2021
59 Vyaire Medical II Jun-15-2023
60 Vyaire Medical I Feb-16-2022
61 Vyaire Medical II Mar-04-2020
62 ZOLL Medical Corporation I Jun-20-2024
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