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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device ventilator, continuous, facility use
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
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
  1.  K222024  Evita V800, Evita V600
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE 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
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24956 24956
2024 17331 17331

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12291 12291
Output Problem 10623 10623
Circuit Failure 6918 6918
Failure to Recalibrate 4696 4696
Battery Problem 4598 4632
Failure to Run on Battery 4179 4179
No Display/Image 4084 4084
Defective Component 3880 3880
Electrical /Electronic Property Problem 3852 3852
Gas/Air Leak 2411 2411
Display or Visual Feedback Problem 2380 2380
Failure to Power Up 2361 2361
Degraded 2225 2225
Failure to Calibrate 2107 2373
Failure to Charge 2009 2025
Failure of Device to Self-Test 1936 1936
Improper Flow or Infusion 1851 1851
Protective Measures Problem 1839 1878
Unexpected Shutdown 1491 1491
Insufficient Information 1453 1453
Contamination 1406 1406
Insufficient Flow or Under Infusion 1401 1401
Infusion or Flow Problem 1288 1288
Power Problem 1235 1277
No Flow 1212 1212
Failure to Deliver 1191 1191
Leak/Splash 1060 1060
Decrease in Pressure 1059 1059
Device Displays Incorrect Message 939 939
Gas Output Problem 936 936
Pressure Problem 840 840
Therapeutic or Diagnostic Output Failure 751 751
Calibration Problem 713 713
Complete Loss of Power 637 637
Application Program Problem 558 558
Adverse Event Without Identified Device or Use Problem 547 547
Computer Software Problem 486 486
Incorrect, Inadequate or Imprecise Result or Readings 483 483
Inadequate User Interface 450 454
Device Alarm System 414 414
Communication or Transmission Problem 406 406
Connection Problem 394 394
Use of Device Problem 371 371
Tidal Volume Fluctuations 309 309
Increase in Pressure 308 308
Loose or Intermittent Connection 250 250
False Positive Result 230 230
Contamination /Decontamination Problem 224 224
Excess Flow or Over-Infusion 217 217
Peeled/Delaminated 214 214

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68523 68523
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1790 1790
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 989 989
No Information 865 865
Unspecified Respiratory Problem 517 517
Headache 345 345
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 276 276
Dizziness 248 248
Dyspnea 241 241
Death 184 184
Respiratory Failure 165 165
Asthma 162 162
Cancer 154 154
Cardiac Arrest 138 138
Unspecified Kidney or Urinary Problem 130 130
Respiratory Tract Infection 128 128
Respiratory Insufficiency 126 126
Nausea 111 111
Skin Inflammation/ Irritation 96 96
Vomiting 90 90
Cough 86 86
Ventilator Dependent 81 81
Inflammation 81 81
Hypoxia 76 76
Sore Throat 76 76
Hypersensitivity/Allergic reaction 71 71
Bradycardia 70 70
No Code Available 66 66
Unspecified Heart Problem 59 59
Respiratory Arrest 52 52
Pneumothorax 52 52
Pneumonia 50 50
Chronic Obstructive Pulmonary Disease (COPD) 44 44
Cyanosis 41 41
Unspecified Hepatic or Biliary Problem 34 34
Hypoventilation 31 31
Low Blood Pressure/ Hypotension 26 26
Discomfort 26 26
Increased Respiratory Rate 25 25
Heart Failure/Congestive Heart Failure 25 25
Loss of consciousness 24 24
Tachycardia 21 21
Chest Pain 21 21
Respiratory Distress 20 20
Apnea 19 19
Patient Problem/Medical Problem 18 18
Unspecified Eye / Vision Problem 17 17

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Oct-22-2024
2 Baxter Healthcare Corporation I Jun-26-2024
3 Baxter Healthcare Corporation I Feb-24-2023
4 Breas Medical, Inc. II Apr-15-2022
5 Covidien I Aug-02-2024
6 Covidien Llc I Dec-09-2021
7 Covidien Llc II Nov-06-2020
8 Draeger Medical, Inc. I Aug-18-2023
9 Draeger Medical, Inc. I Jul-08-2023
10 Draeger Medical, Inc. I Feb-24-2023
11 Draeger Medical, Inc. II Apr-04-2022
12 Draeger Medical, Inc. II Oct-14-2021
13 Draeger Medical, Inc. II May-28-2021
14 GE Healthcare, LLC I Jun-06-2022
15 GE Healthcare, LLC II Aug-24-2020
16 GE Healthcare, LLC II Dec-17-2019
17 Getinge Group Logistics America, LLC II Oct-09-2020
18 Getinge Usa Sales Inc II Aug-24-2022
19 Getinge Usa Sales Inc I Aug-22-2022
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 AG I Jul-11-2019
25 Hamilton Medical, Inc. I Sep-20-2023
26 Hamilton Medical, Inc. I Jul-21-2023
27 Hill-Rom Manufacturing, Inc. II Nov-24-2020
28 Medtronic formerly Covidien I Apr-25-2022
29 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
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 Sep-05-2024
34 Philips Respironics, Inc. I Apr-17-2024
35 Philips Respironics, Inc. II Jan-04-2024
36 Philips Respironics, Inc. II Jul-07-2023
37 Philips Respironics, Inc. I Jun-02-2023
38 Philips Respironics, Inc. I Apr-03-2023
39 Philips Respironics, Inc. I Jan-06-2023
40 Philips Respironics, Inc. I Mar-18-2022
41 Philips Respironics, Inc. I Jan-22-2022
42 Philips Respironics, Inc. II Aug-13-2021
43 Philips Respironics, Inc. I Jul-15-2021
44 Philips Respironics, Inc. I Feb-15-2020
45 ResMed Ltd. I Oct-23-2023
46 Ventec Life Systems, Inc. I Feb-23-2024
47 Ventec Life Systems, Inc. II Jun-21-2021
48 Vyaire Medical II Jun-15-2023
49 Vyaire Medical I Feb-16-2022
50 Vyaire Medical II Mar-04-2020
51 ZOLL Medical Corporation I Jun-20-2024
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