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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 2
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 11105
2021 13322 13333
2022 15974 15986
2023 24928 24932
2024 20336 20339
2025 14197 14200

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12005 12005
Output Problem 11740 11744
Circuit Failure 6935 6935
Electrical /Electronic Property Problem 5760 5760
Battery Problem 5664 5664
Failure to Run on Battery 4830 4831
Failure to Recalibrate 4645 4645
No Display/Image 4195 4195
Defective Component 3856 3856
Failure to Calibrate 3497 3497
Failure of Device to Self-Test 3206 3207
Insufficient Flow or Under Infusion 2844 2844
Failure to Power Up 2839 2842
Gas/Air Leak 2707 2708
Display or Visual Feedback Problem 2481 2481
Degraded 2384 2395
Improper Flow or Infusion 2226 2226
Unexpected Shutdown 1936 1936
Failure to Charge 1935 1935
Power Problem 1649 1650
Insufficient Information 1612 1613
Contamination 1585 1585
Protective Measures Problem 1527 1527
Infusion or Flow Problem 1474 1474
No Flow 1309 1309
Failure to Deliver 1273 1274
Decrease in Pressure 1163 1165
Gas Output Problem 1131 1132
Leak/Splash 1027 1031
Pressure Problem 870 870
Device Displays Incorrect Message 747 747
Complete Loss of Power 715 715
Therapeutic or Diagnostic Output Failure 609 611
Adverse Event Without Identified Device or Use Problem 583 584
Calibration Problem 526 526
Device Sensing Problem 492 492
Computer Software Problem 462 462
Communication or Transmission Problem 417 417
Device Alarm System 412 412
Connection Problem 407 407
Inadequate User Interface 405 405
Application Program Problem 398 398
No Apparent Adverse Event 363 364
Use of Device Problem 362 362
Increase in Pressure 340 340
False Positive Result 294 294
Loose or Intermittent Connection 289 291
Tidal Volume Fluctuations 286 286
Unexpected Therapeutic Results 286 286
Incorrect, Inadequate or Imprecise Result or Readings 281 281

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85081 85100
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2041 2044
Low Oxygen Saturation 1029 1032
Unspecified Respiratory Problem 568 572
No Information 556 556
Headache 374 377
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 290 290
Dizziness 269 269
Dyspnea 262 270
Respiratory Failure 180 180
Asthma 178 178
Cancer 166 167
Cardiac Arrest 152 152
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Hypoxia 98 100
Death 92 95
Cough 91 91
Inflammation 89 89
Ventilator Dependent 83 83
Bradycardia 81 81
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Unspecified Heart Problem 63 63
Respiratory Arrest 62 62
Pneumonia 57 57
Pneumothorax 57 57
Chronic Obstructive Pulmonary Disease (COPD) 54 54
Cyanosis 41 41
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 32 32
Heart Failure/Congestive Heart Failure 32 32
Discomfort 30 30
Apnea 29 29
Increased Respiratory Rate 26 26
Low Blood Pressure/ Hypotension 25 25
Loss of consciousness 22 22
Tachycardia 22 22
Chest Pain 21 21
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
Respiratory Acidosis 16 16
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 Aug-19-2025
23 Hamilton Medical AG I Jun-18-2024
24 Hamilton Medical AG II Apr-25-2023
25 Hamilton Medical AG II Nov-18-2022
26 Hamilton Medical AG I Aug-19-2022
27 Hamilton Medical, Inc. I Sep-20-2023
28 Hamilton Medical, Inc. I Jul-21-2023
29 Hill-Rom Manufacturing, Inc. II Nov-24-2020
30 Maquet Critical Care AB I Jun-27-2025
31 Medtronic formerly Covidien I Apr-25-2022
32 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
33 Percussionaire Corporation I Jan-23-2025
34 Percussionaire Corporation I Jan-17-2024
35 Percussionaire Corporation I Jan-17-2024
36 Percussionaire Corporation II Nov-07-2023
37 Philips Respironics, Inc. I Nov-13-2024
38 Philips Respironics, Inc. I Sep-05-2024
39 Philips Respironics, Inc. I Apr-17-2024
40 Philips Respironics, Inc. II Jan-04-2024
41 Philips Respironics, Inc. II Jul-07-2023
42 Philips Respironics, Inc. I Jun-02-2023
43 Philips Respironics, Inc. I Apr-03-2023
44 Philips Respironics, Inc. I Jan-06-2023
45 Philips Respironics, Inc. I Mar-18-2022
46 Philips Respironics, Inc. I Jan-22-2022
47 Philips Respironics, Inc. II Aug-13-2021
48 Philips Respironics, Inc. I Jul-15-2021
49 Philips Respironics, Inc. I Feb-15-2020
50 ResMed Ltd. I Oct-23-2023
51 Ventec Life Systems, Inc. I Feb-26-2025
52 Ventec Life Systems, Inc. I Feb-23-2024
53 Ventec Life Systems, Inc. II Jun-21-2021
54 Vyaire Medical II Jun-15-2023
55 Vyaire Medical I Feb-16-2022
56 Vyaire Medical II Mar-04-2020
57 ZOLL Medical Corporation I Jun-20-2024
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