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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
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
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20337 20337
2025 6840 6840

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 11102 11102
Mechanical Problem 11012 11012
Circuit Failure 6099 6099
Battery Problem 5435 5435
Electrical /Electronic Property Problem 4753 4753
Failure to Run on Battery 4515 4515
Failure to Recalibrate 4223 4223
No Display/Image 4057 4057
Defective Component 3840 3840
Failure to Power Up 2701 2701
Gas/Air Leak 2607 2607
Failure of Device to Self-Test 2552 2552
Failure to Calibrate 2467 2467
Display or Visual Feedback Problem 2343 2343
Degraded 2304 2304
Insufficient Flow or Under Infusion 2117 2117
Improper Flow or Infusion 1926 1926
Failure to Charge 1871 1871
Unexpected Shutdown 1683 1683
Protective Measures Problem 1520 1520
Insufficient Information 1514 1514
Contamination 1431 1431
Power Problem 1414 1414
Infusion or Flow Problem 1321 1321
Failure to Deliver 1135 1135
No Flow 1131 1131
Decrease in Pressure 1098 1098
Leak/Splash 1020 1020
Gas Output Problem 1000 1000
Pressure Problem 804 804
Device Displays Incorrect Message 746 746
Complete Loss of Power 677 677
Therapeutic or Diagnostic Output Failure 578 578
Adverse Event Without Identified Device or Use Problem 533 533
Calibration Problem 500 500
Computer Software Problem 440 440
Connection Problem 399 399
Application Program Problem 396 396
Inadequate User Interface 391 391
Communication or Transmission Problem 384 384
Device Alarm System 353 353
Use of Device Problem 326 326
Increase in Pressure 311 311
Tidal Volume Fluctuations 274 274
False Positive Result 270 270
Loose or Intermittent Connection 266 266
Unexpected Therapeutic Results 264 264
Fracture 253 253
No Apparent Adverse Event 248 248
Device Sensing Problem 238 238

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78004 78004
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1917 1917
Low Oxygen Saturation 949 949
No Information 556 556
Unspecified Respiratory Problem 543 543
Headache 360 360
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 279 279
Dizziness 259 259
Dyspnea 251 251
Respiratory Failure 169 169
Asthma 168 168
Cancer 159 159
Cardiac Arrest 143 143
Respiratory Insufficiency 137 137
Unspecified Kidney or Urinary Problem 132 132
Respiratory Tract Infection 128 128
Nausea 117 117
Skin Inflammation/ Irritation 100 100
Vomiting 93 93
Death 91 91
Cough 90 90
Inflammation 85 85
Ventilator Dependent 83 83
Hypoxia 79 79
Sore Throat 77 77
Bradycardia 75 75
Hypersensitivity/Allergic reaction 73 73
Respiratory Arrest 62 62
Unspecified Heart Problem 59 59
Pneumothorax 54 54
Pneumonia 52 52
Chronic Obstructive Pulmonary Disease (COPD) 47 47
Cyanosis 37 37
Unspecified Hepatic or Biliary Problem 35 35
Hypoventilation 29 29
Discomfort 29 29
Heart Failure/Congestive Heart Failure 28 28
Apnea 27 27
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
Liver Damage/Dysfunction 14 14

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 Getinge Group Logistics America, LLC II Oct-09-2020
20 Getinge Usa Sales Inc II Aug-24-2022
21 Getinge Usa Sales Inc I Aug-22-2022
22 Hamilton Medical AG I Jun-18-2024
23 Hamilton Medical AG II Apr-25-2023
24 Hamilton Medical AG II Nov-18-2022
25 Hamilton Medical AG I Aug-19-2022
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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