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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
DRAEGERWERK 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 3
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20336 20336
2025 4207 4207

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 10886 10886
Mechanical Problem 10871 10871
Circuit Failure 6008 6008
Battery Problem 5209 5209
Electrical /Electronic Property Problem 4453 4453
Failure to Run on Battery 4414 4414
Failure to Recalibrate 4105 4105
No Display/Image 3981 3981
Defective Component 3834 3834
Gas/Air Leak 2582 2582
Failure to Power Up 2576 2576
Failure of Device to Self-Test 2371 2371
Degraded 2286 2286
Display or Visual Feedback Problem 2278 2278
Failure to Calibrate 2168 2168
Insufficient Flow or Under Infusion 1928 1928
Improper Flow or Infusion 1870 1870
Failure to Charge 1827 1827
Unexpected Shutdown 1615 1615
Protective Measures Problem 1520 1520
Insufficient Information 1470 1470
Contamination 1399 1399
Power Problem 1335 1335
Infusion or Flow Problem 1269 1269
Failure to Deliver 1111 1111
No Flow 1092 1092
Decrease in Pressure 1077 1077
Leak/Splash 1016 1016
Gas Output Problem 968 968
Pressure Problem 791 791
Device Displays Incorrect Message 745 745
Complete Loss of Power 668 668
Therapeutic or Diagnostic Output Failure 570 570
Adverse Event Without Identified Device or Use Problem 519 519
Calibration Problem 498 498
Computer Software Problem 430 430
Connection Problem 396 396
Application Program Problem 395 395
Inadequate User Interface 390 390
Communication or Transmission Problem 377 377
Device Alarm System 334 334
Use of Device Problem 318 318
Increase in Pressure 300 300
Tidal Volume Fluctuations 267 267
Loose or Intermittent Connection 258 258
Unexpected Therapeutic Results 256 256
False Positive Result 256 256
Fracture 234 234
No Apparent Adverse Event 228 228
Contamination /Decontamination Problem 216 216

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75443 75443
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1889 1889
Low Oxygen Saturation 935 935
No Information 556 556
Unspecified Respiratory Problem 538 538
Headache 358 358
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 279 279
Dizziness 257 257
Dyspnea 249 249
Respiratory Failure 169 169
Asthma 166 166
Cancer 159 159
Cardiac Arrest 138 138
Respiratory Insufficiency 132 132
Unspecified Kidney or Urinary Problem 131 131
Respiratory Tract Infection 128 128
Nausea 115 115
Skin Inflammation/ Irritation 100 100
Vomiting 92 92
Death 91 91
Cough 90 90
Inflammation 85 85
Ventilator Dependent 82 82
Hypoxia 77 77
Sore Throat 76 76
Hypersensitivity/Allergic reaction 73 73
Bradycardia 70 70
Respiratory Arrest 60 60
Unspecified Heart Problem 59 59
Pneumonia 51 51
Pneumothorax 46 46
Chronic Obstructive Pulmonary Disease (COPD) 46 46
Cyanosis 37 37
Unspecified Hepatic or Biliary Problem 35 35
Hypoventilation 29 29
Discomfort 29 29
Heart Failure/Congestive Heart Failure 28 28
Apnea 26 26
Low Blood Pressure/ Hypotension 24 24
Increased Respiratory Rate 23 23
Loss of consciousness 22 22
Chest Pain 21 21
Tachycardia 20 20
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 16 16
Respiratory Acidosis 15 15
Stroke/CVA 14 14

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 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, Inc. I Sep-20-2023
25 Hamilton Medical, Inc. I Jul-21-2023
26 Hill-Rom Manufacturing, Inc. II Nov-24-2020
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 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-26-2025
48 Ventec Life Systems, Inc. I Feb-23-2024
49 Ventec Life Systems, Inc. II Jun-21-2021
50 Vyaire Medical II Jun-15-2023
51 Vyaire Medical I Feb-16-2022
52 Vyaire Medical II Mar-04-2020
53 ZOLL Medical Corporation I Jun-20-2024
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