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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 1
  1.  K222207  Babylog VN800, Babylog VN600
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  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
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20336 20336
2025 2759 2759

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12482 12482
Output Problem 11167 11167
Circuit Failure 7066 7066
Battery Problem 5536 5570
Failure to Recalibrate 4740 4740
Electrical /Electronic Property Problem 4438 4438
Failure to Run on Battery 4352 4352
No Display/Image 4318 4318
Defective Component 3909 3909
Failure to Power Up 2772 2772
Gas/Air Leak 2607 2607
Display or Visual Feedback Problem 2448 2448
Failure of Device to Self-Test 2405 2405
Degraded 2295 2295
Failure to Calibrate 2295 2561
Failure to Charge 2184 2200
Improper Flow or Infusion 1932 1932
Protective Measures Problem 1839 1878
Insufficient Flow or Under Infusion 1839 1839
Unexpected Shutdown 1677 1677
Insufficient Information 1564 1564
Contamination 1459 1459
Power Problem 1402 1444
Infusion or Flow Problem 1358 1358
No Flow 1272 1272
Failure to Deliver 1245 1245
Decrease in Pressure 1097 1097
Leak/Splash 1070 1070
Gas Output Problem 1002 1002
Device Displays Incorrect Message 940 940
Pressure Problem 862 862
Therapeutic or Diagnostic Output Failure 783 783
Calibration Problem 721 721
Complete Loss of Power 690 690
Adverse Event Without Identified Device or Use Problem 577 577
Application Program Problem 561 561
Incorrect, Inadequate or Imprecise Result or Readings 491 491
Computer Software Problem 490 490
Inadequate User Interface 451 455
Device Alarm System 434 434
Communication or Transmission Problem 410 410
Connection Problem 404 404
Use of Device Problem 383 383
Increase in Pressure 324 324
Tidal Volume Fluctuations 320 320
Loose or Intermittent Connection 270 270
Unexpected Therapeutic Results 255 255
False Positive Result 244 244
Fracture 232 232
Contamination /Decontamination Problem 226 226

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74092 74092
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1865 1865
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 1033 1033
No Information 865 865
Unspecified Respiratory Problem 535 535
Headache 357 357
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 278 278
Dizziness 256 256
Dyspnea 248 248
Death 184 184
Respiratory Failure 172 172
Asthma 165 165
Cancer 159 159
Cardiac Arrest 145 145
Respiratory Insufficiency 132 132
Unspecified Kidney or Urinary Problem 131 131
Respiratory Tract Infection 128 128
Nausea 115 115
Skin Inflammation/ Irritation 99 99
Vomiting 93 93
Cough 88 88
Inflammation 85 85
Ventilator Dependent 83 83
Hypoxia 83 83
Bradycardia 76 76
Sore Throat 76 76
Hypersensitivity/Allergic reaction 73 73
No Code Available 66 66
Respiratory Arrest 60 60
Unspecified Heart Problem 59 59
Pneumothorax 55 55
Pneumonia 51 51
Chronic Obstructive Pulmonary Disease (COPD) 46 46
Cyanosis 42 42
Unspecified Hepatic or Biliary Problem 35 35
Hypoventilation 32 32
Heart Failure/Congestive Heart Failure 27 27
Discomfort 27 27
Low Blood Pressure/ Hypotension 26 26
Increased Respiratory Rate 26 26
Apnea 26 26
Loss of consciousness 24 24
Tachycardia 23 23
Chest Pain 21 21
Respiratory Distress 20 20
Patient Problem/Medical Problem 18 18
Unspecified Eye / Vision Problem 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jan-16-2025
2 Baxter Healthcare Corporation I Oct-22-2024
3 Baxter Healthcare Corporation I Jun-26-2024
4 Baxter Healthcare Corporation I Feb-24-2023
5 Breas Medical, Inc. II Apr-15-2022
6 Covidien I Aug-02-2024
7 Covidien Llc I Dec-09-2021
8 Covidien Llc II Nov-06-2020
9 Draeger Medical, Inc. I Aug-18-2023
10 Draeger Medical, Inc. I Jul-08-2023
11 Draeger Medical, Inc. I Feb-24-2023
12 Draeger Medical, Inc. II Apr-04-2022
13 Draeger Medical, Inc. II Oct-14-2021
14 Draeger Medical, Inc. II May-28-2021
15 GE Healthcare, LLC I Jun-06-2022
16 GE Healthcare, LLC II Aug-24-2020
17 GE Healthcare, LLC II Dec-17-2019
18 Getinge Group Logistics America, LLC II Oct-09-2020
19 Getinge Usa Sales Inc II Aug-24-2022
20 Getinge Usa Sales Inc I Aug-22-2022
21 Hamilton Medical AG I Jun-18-2024
22 Hamilton Medical AG II Apr-25-2023
23 Hamilton Medical AG II Nov-18-2022
24 Hamilton Medical AG I Aug-19-2022
25 Hamilton Medical AG I Jul-11-2019
26 Hamilton Medical, Inc. I Sep-20-2023
27 Hamilton Medical, Inc. I Jul-21-2023
28 Hill-Rom Manufacturing, Inc. II Nov-24-2020
29 Medtronic formerly Covidien I Apr-25-2022
30 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
31 Percussionaire Corporation I Jan-23-2025
32 Percussionaire Corporation I Jan-17-2024
33 Percussionaire Corporation I Jan-17-2024
34 Percussionaire Corporation II Nov-07-2023
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 Philips Respironics, Inc. I Feb-15-2020
48 ResMed Ltd. I Oct-23-2023
49 Ventec Life Systems, Inc. I Feb-26-2025
50 Ventec Life Systems, Inc. I Feb-23-2024
51 Ventec Life Systems, Inc. II Jun-21-2021
52 Vyaire Medical II Jun-15-2023
53 Vyaire Medical I Feb-16-2022
54 Vyaire Medical II Mar-04-2020
55 ZOLL Medical Corporation I Jun-20-2024
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