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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
  1.  K193056  Puritan Bennett 980 Series Ventilator System
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
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 10103 10104

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 13194 13194
Output Problem 12132 12136
Circuit Failure 7889 7889
Electrical /Electronic Property Problem 7530 7530
Battery Problem 5580 5580
Failure to Run on Battery 5376 5377
Failure to Recalibrate 4989 4989
Failure to Calibrate 4755 4755
No Display/Image 4250 4250
Defective Component 3705 3705
Insufficient Flow or Under Infusion 3653 3653
Failure of Device to Self-Test 2941 2942
Failure to Power Up 2936 2939
Degraded 2776 2787
Gas/Air Leak 2773 2774
Improper Flow or Infusion 2446 2446
Display or Visual Feedback Problem 2243 2243
Unexpected Shutdown 2118 2119
Failure to Charge 1906 1906
Power Problem 1819 1820
Contamination 1687 1687
Insufficient Device Problem Information 1685 1686
Infusion or Flow Problem 1613 1613
No Flow 1454 1454
Failure to Deliver 1395 1396
Gas Output Problem 1306 1307
Device Sensing Problem 1218 1218
Decrease in Pressure 1208 1210
Protective Measures Problem 1081 1081
Leak/Splash 1016 1016
Pressure Problem 904 904
Calibration Problem 840 840
Complete Loss of Power 756 756
Computer Software Problem 680 680
Adverse Event Without Identified Device or Use Problem 654 655
Therapeutic or Diagnostic Output Failure 476 476
Communication or Transmission Problem 444 444
No Apparent Adverse Event 429 430
Connection Problem 400 400
Use of Device Problem 399 399
Application Program Problem 397 397
Inadequate User Interface 364 364
Increase in Pressure 358 358
Device Alarm System 331 331
Fracture 310 312
Loose or Intermittent Connection 305 305
False Positive Result 300 300
Unexpected Therapeutic Results 296 296
Tidal Volume Fluctuations 280 280
Obstruction of Flow 269 269

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 94840 94860
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2194 2197
Low Oxygen Saturation 1139 1142
Unspecified Respiratory Problem 572 576
No Information 556 556
Headache 377 380
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 300 300
No Known Impact Or Consequence To Patient 290 290
Dyspnea 271 279
Dizziness 270 270
Respiratory Failure 182 182
Asthma 178 178
Cardiac Arrest 170 170
Cancer 167 168
Unspecified Kidney or Urinary Problem 142 143
Respiratory Insufficiency 142 142
Eye Irritation 139 139
Respiratory Tract Infection 129 132
Nausea 127 127
Hypoxia 121 123
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Bradycardia 95 95
Death 92 95
Cough 92 92
Inflammation 89 89
Ventilator Dependent 87 87
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 70 70
Unspecified Heart Problem 63 63
Pneumothorax 59 59
Pneumonia 58 58
Chronic Obstructive Pulmonary Disease (COPD) 56 56
Cyanosis 48 48
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 34 34
Heart Failure/Congestive Heart Failure 33 33
Increased Respiratory Rate 32 32
Discomfort 32 32
Apnea 31 31
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 II Aug-14-2026
31 Maquet Critical Care AB I Jun-27-2025
32 Medtronic formerly Covidien I Apr-25-2022
33 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
34 Percussionaire Corporation I Jan-23-2025
35 Percussionaire Corporation I Jan-17-2024
36 Percussionaire Corporation I Jan-17-2024
37 Percussionaire Corporation II Nov-07-2023
38 Philips Respironics, Inc. I Apr-02-2026
39 Philips Respironics, Inc. I Mar-26-2026
40 Philips Respironics, Inc. I Nov-13-2024
41 Philips Respironics, Inc. I Sep-05-2024
42 Philips Respironics, Inc. I Apr-17-2024
43 Philips Respironics, Inc. II Jan-04-2024
44 Philips Respironics, Inc. II Jul-07-2023
45 Philips Respironics, Inc. I Jun-02-2023
46 Philips Respironics, Inc. I Apr-03-2023
47 Philips Respironics, Inc. I Jan-06-2023
48 Philips Respironics, Inc. I Mar-18-2022
49 Philips Respironics, Inc. I Jan-22-2022
50 Philips Respironics, Inc. II Aug-13-2021
51 Philips Respironics, Inc. I Jul-15-2021
52 Philips Respironics, Inc. I Feb-15-2020
53 ResMed Ltd. I Jul-28-2026
54 ResMed Ltd. I Oct-23-2023
55 Ventec Life Systems, Inc. II Jun-23-2026
56 Ventec Life Systems, Inc. I Feb-26-2025
57 Ventec Life Systems, Inc. I Feb-23-2024
58 Ventec Life Systems, Inc. II Jun-21-2021
59 Vyaire Medical II Jun-15-2023
60 Vyaire Medical I Feb-16-2022
61 Vyaire Medical II Mar-04-2020
62 ZOLL Medical Corporation I Jun-20-2024
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