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 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
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
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
  1.  K180098  SERVO-U Ventilator System version 2.1; SERVO-n Ven ...
  2.  K201874  Servo-u Ventilator System 4.1, Servo-n Ventilator ...
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
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 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20336 20336
2025 5635 5635

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12659 12659
Output Problem 11444 11444
Circuit Failure 7166 7166
Battery Problem 5892 5926
Failure to Recalibrate 4829 4829
Electrical /Electronic Property Problem 4711 4711
Failure to Run on Battery 4494 4494
No Display/Image 4416 4416
Defective Component 3916 3916
Failure to Power Up 2900 2900
Gas/Air Leak 2646 2646
Failure of Device to Self-Test 2637 2637
Display or Visual Feedback Problem 2512 2512
Failure to Calibrate 2489 2755
Degraded 2330 2330
Failure to Charge 2234 2250
Insufficient Flow or Under Infusion 2044 2044
Improper Flow or Infusion 2004 2004
Protective Measures Problem 1839 1878
Unexpected Shutdown 1774 1774
Insufficient Information 1607 1607
Contamination 1500 1500
Power Problem 1487 1529
Infusion or Flow Problem 1409 1409
No Flow 1328 1328
Failure to Deliver 1274 1274
Decrease in Pressure 1123 1123
Leak/Splash 1077 1077
Gas Output Problem 1036 1036
Device Displays Incorrect Message 941 941
Pressure Problem 873 873
Therapeutic or Diagnostic Output Failure 795 795
Calibration Problem 723 723
Complete Loss of Power 703 703
Adverse Event Without Identified Device or Use Problem 591 591
Application Program Problem 561 561
Incorrect, Inadequate or Imprecise Result or Readings 498 498
Computer Software Problem 496 496
Inadequate User Interface 452 456
Device Alarm System 443 443
Communication or Transmission Problem 418 418
Connection Problem 406 406
Use of Device Problem 391 391
Increase in Pressure 331 331
Tidal Volume Fluctuations 326 326
Loose or Intermittent Connection 275 275
False Positive Result 264 264
Unexpected Therapeutic Results 261 261
Fracture 247 247
No Apparent Adverse Event 247 247

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76872 76872
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1911 1911
Low Oxygen Saturation 1056 1056
No Known Impact Or Consequence To Patient 1036 1037
No Information 865 865
Unspecified Respiratory Problem 538 538
Headache 359 359
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 279 279
Dizziness 258 258
Dyspnea 253 253
Death 184 184
Respiratory Failure 172 172
Asthma 167 167
Cancer 159 159
Cardiac Arrest 151 151
Respiratory Insufficiency 134 134
Unspecified Kidney or Urinary Problem 131 131
Respiratory Tract Infection 128 128
Nausea 117 117
Skin Inflammation/ Irritation 100 100
Vomiting 94 94
Cough 90 90
Inflammation 85 85
Hypoxia 85 85
Ventilator Dependent 84 84
Bradycardia 80 80
Sore Throat 77 77
Hypersensitivity/Allergic reaction 73 73
No Code Available 66 66
Respiratory Arrest 61 61
Unspecified Heart Problem 59 59
Pneumothorax 55 55
Pneumonia 52 52
Chronic Obstructive Pulmonary Disease (COPD) 47 47
Cyanosis 43 43
Unspecified Hepatic or Biliary Problem 35 35
Hypoventilation 32 32
Discomfort 29 29
Heart Failure/Congestive Heart Failure 28 28
Apnea 27 27
Low Blood Pressure/ Hypotension 27 27
Increased Respiratory Rate 26 26
Loss of consciousness 24 24
Tachycardia 23 23
Chest Pain 21 21
Respiratory Distress 20 20
Unspecified Eye / Vision Problem 18 18
Patient Problem/Medical 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 Aug-02-2024
8 Covidien Llc I Dec-09-2021
9 Covidien Llc II Nov-06-2020
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 GE Healthcare, LLC II Aug-24-2020
18 GE Healthcare, LLC II Dec-17-2019
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 Jun-18-2024
23 Hamilton Medical AG II Apr-25-2023
24 Hamilton Medical AG II Nov-18-2022
25 Hamilton Medical AG I Aug-19-2022
26 Hamilton Medical AG I Jul-11-2019
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 Medtronic formerly Covidien I Apr-25-2022
31 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
32 Percussionaire Corporation I Jan-23-2025
33 Percussionaire Corporation I Jan-17-2024
34 Percussionaire Corporation I Jan-17-2024
35 Percussionaire Corporation II Nov-07-2023
36 Philips Respironics, Inc. I Nov-13-2024
37 Philips Respironics, Inc. I Sep-05-2024
38 Philips Respironics, Inc. I Apr-17-2024
39 Philips Respironics, Inc. II Jan-04-2024
40 Philips Respironics, Inc. II Jul-07-2023
41 Philips Respironics, Inc. I Jun-02-2023
42 Philips Respironics, Inc. I Apr-03-2023
43 Philips Respironics, Inc. I Jan-06-2023
44 Philips Respironics, Inc. I Mar-18-2022
45 Philips Respironics, Inc. I Jan-22-2022
46 Philips Respironics, Inc. II Aug-13-2021
47 Philips Respironics, Inc. I Jul-15-2021
48 Philips Respironics, Inc. I Feb-15-2020
49 ResMed Ltd. I Oct-23-2023
50 Ventec Life Systems, Inc. I Feb-26-2025
51 Ventec Life Systems, Inc. I Feb-23-2024
52 Ventec Life Systems, Inc. II Jun-21-2021
53 Vyaire Medical II Jun-15-2023
54 Vyaire Medical I Feb-16-2022
55 Vyaire Medical II Mar-04-2020
56 ZOLL Medical Corporation I Jun-20-2024
-
-