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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 3
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 3
  1.  K193228  Hamilton-G5
  2.  K201306  HAMILTON-C3
  3.  K201658  Hamilton-C6
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICONIC SOLUTIONS BY MURCIA, SL
  SUBSTANTIALLY EQUIVALENT 1
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 14196 14199
2026 7519 7520

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12928 12928
Output Problem 12022 12026
Circuit Failure 7647 7647
Electrical /Electronic Property Problem 6758 6758
Failure to Run on Battery 5302 5303
Battery Problem 5267 5267
Failure to Recalibrate 4940 4940
Failure to Calibrate 4517 4517
No Display/Image 4193 4193
Defective Component 3703 3703
Insufficient Flow or Under Infusion 3449 3449
Failure to Power Up 2856 2859
Failure of Device to Self-Test 2780 2781
Gas/Air Leak 2752 2753
Degraded 2677 2688
Improper Flow or Infusion 2391 2391
Display or Visual Feedback Problem 2159 2159
Unexpected Shutdown 2030 2031
Failure to Charge 1841 1841
Power Problem 1745 1746
Contamination 1663 1663
Insufficient Device Problem Information 1663 1664
Infusion or Flow Problem 1560 1560
No Flow 1429 1429
Failure to Deliver 1358 1359
Gas Output Problem 1264 1265
Decrease in Pressure 1193 1195
Device Sensing Problem 1084 1084
Protective Measures Problem 1079 1079
Leak/Splash 1013 1013
Pressure Problem 890 890
Calibration Problem 818 818
Complete Loss of Power 733 733
Computer Software Problem 654 654
Adverse Event Without Identified Device or Use Problem 630 631
Therapeutic or Diagnostic Output Failure 457 457
Communication or Transmission Problem 424 424
No Apparent Adverse Event 413 414
Connection Problem 400 400
Application Program Problem 397 397
Use of Device Problem 384 384
Inadequate User Interface 362 362
Increase in Pressure 351 351
Device Alarm System 322 322
Loose or Intermittent Connection 302 302
Fracture 301 303
False Positive Result 299 299
Unexpected Therapeutic Results 292 292
Tidal Volume Fluctuations 276 276
Obstruction of Flow 255 255

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92323 92343
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2170 2173
Low Oxygen Saturation 1114 1117
Unspecified Respiratory Problem 570 574
No Information 556 556
Headache 375 378
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 300 300
No Known Impact Or Consequence To Patient 290 290
Dizziness 269 269
Dyspnea 267 275
Respiratory Failure 181 181
Asthma 178 178
Cancer 167 168
Cardiac Arrest 165 165
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Eye Irritation 139 139
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 117 119
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Death 92 95
Cough 91 91
Bradycardia 91 91
Inflammation 89 89
Ventilator Dependent 87 87
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 67 67
Unspecified Heart Problem 63 63
Pneumonia 58 58
Pneumothorax 58 58
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 47 47
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 34 34
Heart Failure/Congestive Heart Failure 33 33
Discomfort 31 31
Apnea 31 31
Increased Respiratory Rate 30 30
Low Blood Pressure/ Hypotension 29 29
Tachycardia 25 25
Loss of consciousness 25 25
Chest Pain 21 21
Respiratory Acidosis 20 20
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17

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 Apr-02-2026
38 Philips Respironics, Inc. I Mar-26-2026
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. II Jun-23-2026
54 Ventec Life Systems, Inc. I Feb-26-2025
55 Ventec Life Systems, Inc. I Feb-23-2024
56 Ventec Life Systems, Inc. II Jun-21-2021
57 Vyaire Medical II Jun-15-2023
58 Vyaire Medical I Feb-16-2022
59 Vyaire Medical II Mar-04-2020
60 ZOLL Medical Corporation I Jun-20-2024
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