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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
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 2
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
  1.  K202970  Ventway Sparrow
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 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
2019 9100 9504
2020 11096 11104
2021 13322 13328
2022 15974 15976
2023 24928 24928
2024 20336 20336
2025 12074 12077

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 13304 13304
Output Problem 11987 11988
Circuit Failure 7791 7791
Battery Problem 6136 6170
Electrical /Electronic Property Problem 5522 5522
Failure to Recalibrate 5301 5301
Failure to Run on Battery 4753 4753
No Display/Image 4560 4560
Defective Component 3925 3925
Failure to Calibrate 3293 3559
Failure of Device to Self-Test 3163 3164
Failure to Power Up 3048 3048
Gas/Air Leak 2717 2717
Display or Visual Feedback Problem 2628 2628
Insufficient Flow or Under Infusion 2625 2625
Degraded 2415 2415
Failure to Charge 2304 2320
Improper Flow or Infusion 2225 2225
Unexpected Shutdown 1982 1982
Protective Measures Problem 1843 1882
Power Problem 1696 1738
Insufficient Information 1692 1692
Contamination 1629 1629
Infusion or Flow Problem 1554 1554
No Flow 1458 1458
Failure to Deliver 1366 1366
Decrease in Pressure 1178 1179
Gas Output Problem 1149 1149
Leak/Splash 1082 1086
Device Displays Incorrect Message 941 941
Pressure Problem 919 919
Therapeutic or Diagnostic Output Failure 824 826
Calibration Problem 749 749
Complete Loss of Power 728 728
Adverse Event Without Identified Device or Use Problem 631 631
Application Program Problem 564 564
Incorrect, Inadequate or Imprecise Result or Readings 520 520
Computer Software Problem 518 518
Device Alarm System 493 493
Inadequate User Interface 461 465
Communication or Transmission Problem 442 442
Use of Device Problem 417 417
Connection Problem 413 413
Device Sensing Problem 411 411
Increase in Pressure 357 357
No Apparent Adverse Event 343 343
Tidal Volume Fluctuations 339 339
Loose or Intermittent Connection 299 301
Unexpected Therapeutic Results 283 283
False Positive Result 282 282

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83066 83075
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1998 2000
Low Oxygen Saturation 1111 1113
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 565 565
Headache 375 375
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
Dizziness 270 270
Dyspnea 261 263
Death 185 187
Respiratory Failure 180 180
Asthma 176 176
Cancer 167 167
Cardiac Arrest 156 156
Respiratory Insufficiency 141 141
Unspecified Kidney or Urinary Problem 140 140
Respiratory Tract Infection 129 129
Nausea 126 126
Skin Inflammation/ Irritation 107 107
Vomiting 102 102
Hypoxia 96 98
Cough 91 91
Bradycardia 89 89
Inflammation 89 89
Ventilator Dependent 84 84
Sore Throat 77 77
Hypersensitivity/Allergic reaction 75 75
Pneumothorax 66 66
No Code Available 66 66
Unspecified Heart Problem 63 63
Respiratory Arrest 61 61
Pneumonia 55 55
Chronic Obstructive Pulmonary Disease (COPD) 54 54
Cyanosis 46 46
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 32 32
Heart Failure/Congestive Heart Failure 31 31
Apnea 29 29
Increased Respiratory Rate 29 29
Low Blood Pressure/ Hypotension 28 28
Discomfort 28 28
Tachycardia 24 24
Loss of consciousness 24 24
Chest Pain 21 21
Respiratory Distress 20 20
Patient Problem/Medical Problem 18 18
Unspecified Eye / Vision Problem 18 18

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 GE Healthcare, LLC II Dec-17-2019
20 Getinge Group Logistics America, LLC II Oct-09-2020
21 Getinge Usa Sales Inc II Aug-24-2022
22 Getinge Usa Sales Inc I Aug-22-2022
23 Hamilton Medical AG I Aug-19-2025
24 Hamilton Medical AG I Jun-18-2024
25 Hamilton Medical AG II Apr-25-2023
26 Hamilton Medical AG II Nov-18-2022
27 Hamilton Medical AG I Aug-19-2022
28 Hamilton Medical AG I Jul-11-2019
29 Hamilton Medical, Inc. I Sep-20-2023
30 Hamilton Medical, Inc. I Jul-21-2023
31 Hill-Rom Manufacturing, Inc. II Nov-24-2020
32 Maquet Critical Care AB I Jun-27-2025
33 Medtronic formerly Covidien I Apr-25-2022
34 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
35 Percussionaire Corporation I Jan-23-2025
36 Percussionaire Corporation I Jan-17-2024
37 Percussionaire Corporation I Jan-17-2024
38 Percussionaire Corporation II Nov-07-2023
39 Philips Respironics, Inc. I Nov-13-2024
40 Philips Respironics, Inc. I Sep-05-2024
41 Philips Respironics, Inc. I Apr-17-2024
42 Philips Respironics, Inc. II Jan-04-2024
43 Philips Respironics, Inc. II Jul-07-2023
44 Philips Respironics, Inc. I Jun-02-2023
45 Philips Respironics, Inc. I Apr-03-2023
46 Philips Respironics, Inc. I Jan-06-2023
47 Philips Respironics, Inc. I Mar-18-2022
48 Philips Respironics, Inc. I Jan-22-2022
49 Philips Respironics, Inc. II Aug-13-2021
50 Philips Respironics, Inc. I Jul-15-2021
51 Philips Respironics, Inc. I Feb-15-2020
52 ResMed Ltd. I Oct-23-2023
53 Ventec Life Systems, Inc. I Feb-26-2025
54 Ventec Life Systems, Inc. I Feb-23-2024
55 Ventec Life Systems, Inc. II Jun-21-2021
56 Vyaire Medical II Jun-15-2023
57 Vyaire Medical I Feb-16-2022
58 Vyaire Medical II Mar-04-2020
59 ZOLL Medical Corporation I Jun-20-2024
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