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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
  1.  K203449  F&P Visairo NIV Mask Range
  2.  K252173  F&P OptiNIV Hospital Vented Full Face Mask Compati ...
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
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 5111 5112

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 14354 14354
Output Problem 12423 12427
Circuit Failure 8506 8506
Electrical /Electronic Property Problem 6447 6447
Battery Problem 6378 6412
Failure to Recalibrate 5572 5572
Failure to Run on Battery 5162 5163
No Display/Image 4673 4673
Failure to Calibrate 4368 4634
Defective Component 3938 3938
Failure of Device to Self-Test 3723 3724
Insufficient Flow or Under Infusion 3277 3277
Failure to Power Up 3157 3160
Gas/Air Leak 2803 2804
Degraded 2778 2789
Display or Visual Feedback Problem 2770 2770
Improper Flow or Infusion 2450 2450
Failure to Charge 2343 2359
Unexpected Shutdown 2178 2179
Power Problem 1879 1922
Protective Measures Problem 1850 1889
Insufficient Information 1767 1768
Contamination 1727 1727
Infusion or Flow Problem 1651 1651
No Flow 1599 1599
Failure to Deliver 1486 1487
Gas Output Problem 1273 1274
Decrease in Pressure 1217 1219
Leak/Splash 1093 1097
Calibration Problem 992 992
Pressure Problem 987 987
Device Displays Incorrect Message 942 942
Device Sensing Problem 937 937
Therapeutic or Diagnostic Output Failure 860 862
Complete Loss of Power 758 758
Computer Software Problem 689 689
Adverse Event Without Identified Device or Use Problem 683 684
Application Program Problem 565 565
Incorrect, Inadequate or Imprecise Result or Readings 560 560
Device Alarm System 547 547
Inadequate User Interface 476 480
Communication or Transmission Problem 470 470
Use of Device Problem 448 448
Connection Problem 419 419
No Apparent Adverse Event 409 410
Increase in Pressure 380 380
Tidal Volume Fluctuations 350 350
Loose or Intermittent Connection 318 320
False Positive Result 299 299
Unexpected Therapeutic Results 293 293

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90071 90091
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2123 2126
Low Oxygen Saturation 1180 1183
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 569 573
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 298 298
Dizziness 269 269
Dyspnea 266 274
Death 185 188
Respiratory Failure 184 184
Asthma 178 178
Cardiac Arrest 168 168
Cancer 167 168
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 115 117
Skin Inflammation/ Irritation 107 107
Vomiting 102 102
Bradycardia 97 97
Cough 91 91
Inflammation 89 89
Ventilator Dependent 84 84
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Pneumothorax 66 66
No Code Available 66 66
Respiratory Arrest 65 65
Unspecified Heart Problem 63 63
Pneumonia 58 58
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 50 50
Hypoventilation 37 37
Unspecified Hepatic or Biliary Problem 36 36
Heart Failure/Congestive Heart Failure 32 32
Increased Respiratory Rate 32 32
Discomfort 30 30
Apnea 30 30
Low Blood Pressure/ Hypotension 29 29
Tachycardia 27 27
Loss of consciousness 27 27
Chest Pain 21 21
Respiratory Distress 20 20
Respiratory Acidosis 19 19
Pulmonary Dysfunction 18 18

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. I Feb-26-2025
56 Ventec Life Systems, Inc. I Feb-23-2024
57 Ventec Life Systems, Inc. II Jun-21-2021
58 Vyaire Medical II Jun-15-2023
59 Vyaire Medical I Feb-16-2022
60 Vyaire Medical II Mar-04-2020
61 ZOLL Medical Corporation I Jun-20-2024
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