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

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 11274 11278
Mechanical Problem 10494 10494
Circuit Failure 6407 6407
Electrical /Electronic Property Problem 6257 6257
Failure to Run on Battery 5197 5198
Battery Problem 5067 5067
Failure to Recalibrate 4098 4098
No Display/Image 3880 3880
Failure to Calibrate 3832 3832
Defective Component 3752 3752
Insufficient Flow or Under Infusion 3350 3350
Failure of Device to Self-Test 3078 3079
Gas/Air Leak 2737 2738
Degraded 2654 2665
Failure to Power Up 2652 2655
Display or Visual Feedback Problem 2358 2358
Improper Flow or Infusion 2254 2254
Unexpected Shutdown 1855 1856
Power Problem 1602 1603
Contamination 1552 1552
Failure to Charge 1483 1483
Insufficient Information 1471 1471
Infusion or Flow Problem 1372 1372
No Flow 1242 1242
Failure to Deliver 1155 1156
Decrease in Pressure 1074 1076
Gas Output Problem 1056 1057
Device Sensing Problem 984 984
Protective Measures Problem 970 970
Leak/Splash 921 921
Pressure Problem 767 767
Calibration Problem 686 686
Complete Loss of Power 662 662
Computer Software Problem 631 631
Adverse Event Without Identified Device or Use Problem 583 584
Therapeutic or Diagnostic Output Failure 476 478
Device Displays Incorrect Message 459 459
Connection Problem 406 406
No Apparent Adverse Event 394 395
Communication or Transmission Problem 361 361
Device Alarm System 359 359
Increase in Pressure 348 348
Use of Device Problem 311 311
Application Program Problem 306 306
Loose or Intermittent Connection 300 302
False Positive Result 299 299
Unexpected Therapeutic Results 291 291
Inadequate User Interface 290 290
Fracture 290 292
Obstruction of Flow 248 248

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89135 89151
Insufficient Information 2080 2083
Low Oxygen Saturation 990 991
Unspecified Respiratory Problem 569 573
No Consequences Or Impact To Patient 534 534
Headache 375 378
No Patient Involvement 306 307
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 291 291
Dizziness 269 269
Dyspnea 258 266
Asthma 178 178
Respiratory Failure 175 175
Cancer 167 168
Cardiac Arrest 153 153
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 102 104
Vomiting 101 101
Cough 91 91
Inflammation 89 89
Ventilator Dependent 87 87
Bradycardia 78 78
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 62 62
Unspecified Heart Problem 62 62
Pneumonia 55 55
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Pneumothorax 47 47
No Information 40 40
Cyanosis 38 38
Unspecified Hepatic or Biliary Problem 36 36
Heart Failure/Congestive Heart Failure 32 32
Discomfort 31 31
Increased Respiratory Rate 30 30
Apnea 27 27
Hypoventilation 24 24
Low Blood Pressure/ Hypotension 23 23
Chest Pain 21 21
Loss of consciousness 21 21
Death 19 19
Tachycardia 19 19
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
Respiratory Acidosis 16 16
Stroke/CVA 15 15
Liver Damage/Dysfunction 14 14

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 Apr-02-2026
34 Philips Respironics, Inc. I Mar-26-2026
35 Philips Respironics, Inc. I Nov-13-2024
36 Philips Respironics, Inc. I Sep-05-2024
37 Philips Respironics, Inc. I Apr-17-2024
38 Philips Respironics, Inc. II Jan-04-2024
39 Philips Respironics, Inc. II Jul-07-2023
40 Philips Respironics, Inc. I Jun-02-2023
41 Philips Respironics, Inc. I Apr-03-2023
42 Philips Respironics, Inc. I Jan-06-2023
43 Philips Respironics, Inc. I Mar-18-2022
44 Philips Respironics, Inc. I Jan-22-2022
45 Philips Respironics, Inc. II Aug-13-2021
46 Philips Respironics, Inc. I Jul-15-2021
47 ResMed Ltd. I Oct-23-2023
48 Ventec Life Systems, Inc. I Feb-26-2025
49 Ventec Life Systems, Inc. I Feb-23-2024
50 Ventec Life Systems, Inc. II Jun-21-2021
51 Vyaire Medical II Jun-15-2023
52 Vyaire Medical I Feb-16-2022
53 ZOLL Medical Corporation I Jun-20-2024
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