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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
  1.  K193056  Puritan Bennett 980 Series Ventilator System
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 20335 20335
2025 1513 1513

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 10719 10719
Output Problem 10704 10704
Circuit Failure 5901 5901
Battery Problem 4786 4786
Failure to Run on Battery 4289 4289
Electrical /Electronic Property Problem 4177 4177
Failure to Recalibrate 4015 4015
No Display/Image 3872 3872
Defective Component 3831 3831
Gas/Air Leak 2523 2523
Failure to Power Up 2467 2467
Degraded 2248 2248
Display or Visual Feedback Problem 2238 2238
Failure of Device to Self-Test 2101 2101
Failure to Calibrate 2022 2022
Improper Flow or Infusion 1817 1817
Failure to Charge 1753 1753
Insufficient Flow or Under Infusion 1729 1729
Protective Measures Problem 1520 1520
Unexpected Shutdown 1510 1510
Insufficient Information 1437 1437
Contamination 1357 1357
Power Problem 1267 1267
Infusion or Flow Problem 1222 1222
Failure to Deliver 1088 1088
Decrease in Pressure 1055 1055
No Flow 1050 1050
Leak/Splash 1010 1010
Gas Output Problem 929 929
Pressure Problem 774 774
Device Displays Incorrect Message 745 745
Complete Loss of Power 650 650
Therapeutic or Diagnostic Output Failure 557 557
Adverse Event Without Identified Device or Use Problem 500 500
Calibration Problem 495 495
Computer Software Problem 428 428
Connection Problem 395 395
Application Program Problem 394 394
Inadequate User Interface 390 390
Communication or Transmission Problem 371 371
Device Alarm System 326 326
Use of Device Problem 313 313
Increase in Pressure 294 294
Tidal Volume Fluctuations 264 264
Loose or Intermittent Connection 255 255
Unexpected Therapeutic Results 252 252
False Positive Result 235 235
Fracture 222 222
Contamination /Decontamination Problem 214 214
Excess Flow or Over-Infusion 214 214

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72848 72848
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1839 1839
Low Oxygen Saturation 921 921
No Information 556 556
Unspecified Respiratory Problem 533 533
Headache 353 353
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 277 277
Dizziness 254 254
Dyspnea 245 245
Respiratory Failure 166 166
Asthma 165 165
Cancer 159 159
Cardiac Arrest 134 134
Respiratory Insufficiency 131 131
Unspecified Kidney or Urinary Problem 131 131
Respiratory Tract Infection 128 128
Nausea 113 113
Skin Inflammation/ Irritation 99 99
Vomiting 91 91
Death 91 91
Cough 88 88
Inflammation 85 85
Ventilator Dependent 80 80
Sore Throat 76 76
Hypoxia 75 75
Hypersensitivity/Allergic reaction 72 72
Bradycardia 68 68
Unspecified Heart Problem 59 59
Respiratory Arrest 57 57
Pneumonia 51 51
Chronic Obstructive Pulmonary Disease (COPD) 46 46
Pneumothorax 44 44
Cyanosis 36 36
Unspecified Hepatic or Biliary Problem 34 34
Hypoventilation 29 29
Heart Failure/Congestive Heart Failure 27 27
Discomfort 27 27
Apnea 25 25
Low Blood Pressure/ Hypotension 23 23
Increased Respiratory Rate 23 23
Loss of consciousness 22 22
Chest Pain 21 21
Tachycardia 19 19
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-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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