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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
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210384  CARESCAPE R860
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 1
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICONIC SOLUTIONS BY MURCIA, SL
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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
Output Problem 11242 11246
Mechanical Problem 10624 10624
Circuit Failure 6552 6552
Electrical /Electronic Property Problem 6492 6492
Failure to Run on Battery 5275 5276
Battery Problem 4613 4613
Failure to Recalibrate 4097 4097
Failure to Calibrate 3994 3994
No Display/Image 3844 3844
Defective Component 3695 3695
Insufficient Flow or Under Infusion 3445 3445
Gas/Air Leak 2739 2740
Degraded 2628 2639
Failure to Power Up 2623 2626
Failure of Device to Self-Test 2589 2590
Improper Flow or Infusion 2273 2273
Display or Visual Feedback Problem 1990 1990
Unexpected Shutdown 1835 1836
Power Problem 1588 1589
Contamination 1563 1563
Insufficient Device Problem Information 1477 1477
Failure to Charge 1442 1442
Infusion or Flow Problem 1378 1378
No Flow 1258 1258
Failure to Deliver 1169 1170
Decrease in Pressure 1078 1080
Gas Output Problem 1074 1075
Device Sensing Problem 1073 1073
Leak/Splash 908 908
Pressure Problem 752 752
Calibration Problem 705 705
Complete Loss of Power 666 666
Computer Software Problem 632 632
Protective Measures Problem 605 605
Adverse Event Without Identified Device or Use Problem 590 591
No Apparent Adverse Event 404 405
Connection Problem 397 397
Therapeutic or Diagnostic Output Failure 388 388
Communication or Transmission Problem 357 357
Increase in Pressure 346 346
Device Alarm System 311 311
Use of Device Problem 310 310
Application Program Problem 304 304
Loose or Intermittent Connection 300 300
False Positive Result 299 299
Fracture 297 299
Unexpected Therapeutic Results 289 289
Inadequate User Interface 248 248
Obstruction of Flow 240 240
Charging Problem 235 235

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90292 90308
Insufficient Information 2103 2106
Low Oxygen Saturation 1009 1010
Unspecified Respiratory Problem 569 573
No Consequences Or Impact To Patient 534 534
Headache 375 378
No Patient Involvement 306 307
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 293 293
Dizziness 269 269
Dyspnea 259 267
Asthma 178 178
Respiratory Failure 175 175
Cancer 167 168
Cardiac Arrest 157 157
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Eye Irritation 139 139
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 110 112
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Cough 91 91
Inflammation 89 89
Ventilator Dependent 87 87
Bradycardia 79 79
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 64 64
Unspecified Heart Problem 62 62
Pneumonia 55 55
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Pneumothorax 48 48
No Information 40 40
Cyanosis 39 39
Unspecified Hepatic or Biliary Problem 36 36
Heart Failure/Congestive Heart Failure 33 33
Discomfort 31 31
Increased Respiratory Rate 30 30
Apnea 28 28
Low Blood Pressure/ Hypotension 25 25
Hypoventilation 24 24
Chest Pain 21 21
Loss of consciousness 21 21
Tachycardia 20 20
Death 19 19
Unspecified Eye / Vision Problem 18 18
Respiratory Acidosis 17 17
Pulmonary Dysfunction 17 17
Delirium 16 16

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 Draeger Medical, Inc. I Aug-18-2023
11 Draeger Medical, Inc. I Jul-08-2023
12 Draeger Medical, Inc. I Feb-24-2023
13 Draeger Medical, Inc. II Apr-04-2022
14 Draeger Medical, Inc. II Oct-14-2021
15 Draeger Medical, Inc. II May-28-2021
16 GE Healthcare, LLC I Jun-06-2022
17 Getinge Usa Sales Inc II Aug-24-2022
18 Getinge Usa Sales Inc I Aug-22-2022
19 Hamilton Medical AG I Aug-19-2025
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 Maquet Critical Care AB I Jun-27-2025
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 Apr-02-2026
34 Philips Respironics, Inc. I Mar-26-2026
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 ResMed Ltd. I Oct-23-2023
48 Ventec Life Systems, Inc. II Jun-23-2026
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 ZOLL Medical Corporation I Jun-20-2024
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