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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
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
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 2
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

MDR Year MDR Reports MDR Events
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 18910 18910

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12334 12334
Output Problem 10867 10867
Circuit Failure 6964 6964
Battery Problem 4886 4920
Failure to Recalibrate 4705 4705
Failure to Run on Battery 4213 4213
No Display/Image 4162 4162
Electrical /Electronic Property Problem 3986 3986
Defective Component 3907 3907
Failure to Power Up 2540 2540
Gas/Air Leak 2456 2456
Display or Visual Feedback Problem 2404 2404
Degraded 2237 2237
Failure to Calibrate 2149 2415
Failure to Charge 2051 2067
Failure of Device to Self-Test 1949 1949
Improper Flow or Infusion 1874 1874
Protective Measures Problem 1839 1878
Unexpected Shutdown 1521 1521
Insufficient Flow or Under Infusion 1496 1496
Insufficient Information 1489 1489
Contamination 1417 1417
Infusion or Flow Problem 1293 1293
Power Problem 1280 1322
No Flow 1227 1227
Failure to Deliver 1204 1204
Decrease in Pressure 1070 1070
Leak/Splash 1062 1062
Gas Output Problem 949 949
Device Displays Incorrect Message 939 939
Pressure Problem 845 845
Therapeutic or Diagnostic Output Failure 760 760
Calibration Problem 714 714
Complete Loss of Power 650 650
Application Program Problem 559 559
Adverse Event Without Identified Device or Use Problem 556 556
Computer Software Problem 488 488
Incorrect, Inadequate or Imprecise Result or Readings 486 486
Inadequate User Interface 450 454
Device Alarm System 414 414
Communication or Transmission Problem 406 406
Connection Problem 395 395
Use of Device Problem 372 372
Tidal Volume Fluctuations 310 310
Increase in Pressure 308 308
Loose or Intermittent Connection 259 259
False Positive Result 230 230
Unexpected Therapeutic Results 226 226
Contamination /Decontamination Problem 225 225
Excess Flow or Over-Infusion 217 217

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70055 70055
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1810 1810
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 1001 1001
No Information 865 865
Unspecified Respiratory Problem 523 523
Headache 348 348
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 277 277
Dizziness 249 249
Dyspnea 247 247
Death 184 184
Respiratory Failure 167 167
Asthma 163 163
Cancer 154 154
Cardiac Arrest 139 139
Unspecified Kidney or Urinary Problem 130 130
Respiratory Tract Infection 128 128
Respiratory Insufficiency 126 126
Nausea 111 111
Skin Inflammation/ Irritation 97 97
Vomiting 90 90
Cough 88 88
Inflammation 82 82
Ventilator Dependent 81 81
Hypoxia 78 78
Sore Throat 76 76
Bradycardia 73 73
Hypersensitivity/Allergic reaction 71 71
No Code Available 66 66
Unspecified Heart Problem 59 59
Respiratory Arrest 52 52
Pneumothorax 52 52
Pneumonia 50 50
Chronic Obstructive Pulmonary Disease (COPD) 45 45
Cyanosis 42 42
Unspecified Hepatic or Biliary Problem 34 34
Hypoventilation 31 31
Discomfort 26 26
Low Blood Pressure/ Hypotension 26 26
Increased Respiratory Rate 25 25
Heart Failure/Congestive Heart Failure 25 25
Loss of consciousness 24 24
Tachycardia 21 21
Chest Pain 21 21
Respiratory Distress 20 20
Apnea 19 19
Unspecified Eye / Vision Problem 18 18
Patient Problem/Medical Problem 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Oct-22-2024
2 Baxter Healthcare Corporation I Jun-26-2024
3 Baxter Healthcare Corporation I Feb-24-2023
4 Breas Medical, Inc. II Apr-15-2022
5 Covidien I Aug-02-2024
6 Covidien Llc I Dec-09-2021
7 Covidien Llc II Nov-06-2020
8 Draeger Medical, Inc. I Aug-18-2023
9 Draeger Medical, Inc. I Jul-08-2023
10 Draeger Medical, Inc. I Feb-24-2023
11 Draeger Medical, Inc. II Apr-04-2022
12 Draeger Medical, Inc. II Oct-14-2021
13 Draeger Medical, Inc. II May-28-2021
14 GE Healthcare, LLC I Jun-06-2022
15 GE Healthcare, LLC II Aug-24-2020
16 GE Healthcare, LLC II Dec-17-2019
17 Getinge Group Logistics America, LLC II Oct-09-2020
18 Getinge Usa Sales Inc II Aug-24-2022
19 Getinge Usa Sales Inc I Aug-22-2022
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 AG I Jul-11-2019
25 Hamilton Medical, Inc. I Sep-20-2023
26 Hamilton Medical, Inc. I Jul-21-2023
27 Hill-Rom Manufacturing, Inc. II Nov-24-2020
28 Medtronic formerly Covidien I Apr-25-2022
29 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
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 Nov-13-2024
34 Philips Respironics, Inc. I Sep-05-2024
35 Philips Respironics, Inc. I Apr-17-2024
36 Philips Respironics, Inc. II Jan-04-2024
37 Philips Respironics, Inc. II Jul-07-2023
38 Philips Respironics, Inc. I Jun-02-2023
39 Philips Respironics, Inc. I Apr-03-2023
40 Philips Respironics, Inc. I Jan-06-2023
41 Philips Respironics, Inc. I Mar-18-2022
42 Philips Respironics, Inc. I Jan-22-2022
43 Philips Respironics, Inc. II Aug-13-2021
44 Philips Respironics, Inc. I Jul-15-2021
45 Philips Respironics, Inc. I Feb-15-2020
46 ResMed Ltd. I Oct-23-2023
47 Ventec Life Systems, Inc. I Feb-23-2024
48 Ventec Life Systems, Inc. II Jun-21-2021
49 Vyaire Medical II Jun-15-2023
50 Vyaire Medical I Feb-16-2022
51 Vyaire Medical II Mar-04-2020
52 ZOLL Medical Corporation I Jun-20-2024
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