Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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 8740 8741

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 13099 13099
Output Problem 12084 12088
Circuit Failure 7770 7770
Electrical /Electronic Property Problem 7040 7040
Battery Problem 5397 5397
Failure to Run on Battery 5338 5339
Failure to Recalibrate 4983 4983
Failure to Calibrate 4633 4633
No Display/Image 4220 4220
Defective Component 3704 3704
Insufficient Flow or Under Infusion 3558 3558
Failure to Power Up 2874 2877
Failure of Device to Self-Test 2844 2845
Gas/Air Leak 2761 2762
Degraded 2727 2738
Improper Flow or Infusion 2414 2414
Display or Visual Feedback Problem 2210 2210
Unexpected Shutdown 2071 2072
Failure to Charge 1899 1899
Power Problem 1773 1774
Insufficient Device Problem Information 1674 1675
Contamination 1669 1669
Infusion or Flow Problem 1578 1578
No Flow 1441 1441
Failure to Deliver 1380 1381
Gas Output Problem 1282 1283
Decrease in Pressure 1203 1205
Device Sensing Problem 1149 1149
Protective Measures Problem 1080 1080
Leak/Splash 1016 1016
Pressure Problem 900 900
Calibration Problem 830 830
Complete Loss of Power 741 741
Computer Software Problem 666 666
Adverse Event Without Identified Device or Use Problem 643 644
Therapeutic or Diagnostic Output Failure 466 466
Communication or Transmission Problem 432 432
No Apparent Adverse Event 419 420
Connection Problem 400 400
Application Program Problem 397 397
Use of Device Problem 390 390
Inadequate User Interface 362 362
Increase in Pressure 354 354
Device Alarm System 324 324
Fracture 306 308
Loose or Intermittent Connection 305 305
False Positive Result 299 299
Unexpected Therapeutic Results 295 295
Tidal Volume Fluctuations 279 279
Obstruction of Flow 258 258

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93506 93526
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2184 2187
Low Oxygen Saturation 1126 1129
Unspecified Respiratory Problem 572 576
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
Dyspnea 269 277
Dizziness 269 269
Respiratory Failure 182 182
Asthma 178 178
Cardiac Arrest 169 169
Cancer 167 168
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Eye Irritation 139 139
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 119 121
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Bradycardia 93 93
Death 92 95
Cough 91 91
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
Pneumonia 58 58
Pneumothorax 58 58
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 48 48
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 Jul-28-2026
53 ResMed Ltd. I Oct-23-2023
54 Ventec Life Systems, Inc. II Jun-23-2026
55 Ventec Life Systems, Inc. I Feb-26-2025
56 Ventec Life Systems, Inc. I Feb-23-2024
57 Ventec Life Systems, Inc. II Jun-21-2021
58 Vyaire Medical II Jun-15-2023
59 Vyaire Medical I Feb-16-2022
60 Vyaire Medical II Mar-04-2020
61 ZOLL Medical Corporation I Jun-20-2024
-
-