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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
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
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 3
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
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20334 20334

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 10682 10682
Output Problem 10600 10600
Circuit Failure 5868 5868
Battery Problem 4530 4530
Failure to Run on Battery 4249 4249
Electrical /Electronic Property Problem 4010 4010
Failure to Recalibrate 4008 4008
Defective Component 3831 3831
No Display/Image 3824 3824
Gas/Air Leak 2470 2470
Failure to Power Up 2364 2364
Degraded 2234 2234
Display or Visual Feedback Problem 2221 2221
Failure to Calibrate 1995 1995
Failure of Device to Self-Test 1901 1901
Improper Flow or Infusion 1794 1794
Failure to Charge 1702 1702
Insufficient Flow or Under Infusion 1618 1618
Protective Measures Problem 1520 1520
Unexpected Shutdown 1456 1456
Insufficient Information 1403 1403
Contamination 1343 1343
Power Problem 1228 1228
Infusion or Flow Problem 1191 1191
Failure to Deliver 1067 1067
Decrease in Pressure 1050 1050
No Flow 1038 1038
Leak/Splash 1006 1006
Gas Output Problem 910 910
Pressure Problem 769 769
Device Displays Incorrect Message 745 745
Complete Loss of Power 633 633
Therapeutic or Diagnostic Output Failure 549 549
Adverse Event Without Identified Device or Use Problem 494 494
Calibration Problem 491 491
Computer Software Problem 427 427
Application Program Problem 394 394
Inadequate User Interface 390 390
Connection Problem 388 388
Communication or Transmission Problem 371 371
Device Alarm System 315 315
Use of Device Problem 307 307
Increase in Pressure 285 285
Tidal Volume Fluctuations 262 262
Loose or Intermittent Connection 251 251
Unexpected Therapeutic Results 238 238
False Positive Result 234 234
Fracture 216 216
Contamination /Decontamination Problem 214 214
Peeled/Delaminated 213 213

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71389 71389
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1819 1819
Low Oxygen Saturation 907 907
No Information 556 556
Unspecified Respiratory Problem 532 532
Headache 353 353
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 277 277
Dizziness 254 254
Dyspnea 245 245
Respiratory Failure 166 166
Asthma 165 165
Cancer 159 159
Cardiac Arrest 130 130
Unspecified Kidney or Urinary Problem 130 130
Respiratory Tract Infection 128 128
Respiratory Insufficiency 126 126
Nausea 113 113
Skin Inflammation/ Irritation 99 99
Vomiting 91 91
Death 91 91
Cough 88 88
Inflammation 85 85
Ventilator Dependent 80 80
Sore Throat 76 76
Hypersensitivity/Allergic reaction 72 72
Hypoxia 71 71
Bradycardia 67 67
Unspecified Heart Problem 59 59
Respiratory Arrest 53 53
Pneumonia 51 51
Chronic Obstructive Pulmonary Disease (COPD) 46 46
Pneumothorax 44 44
Cyanosis 36 36
Unspecified Hepatic or Biliary Problem 34 34
Hypoventilation 29 29
Discomfort 26 26
Heart Failure/Congestive Heart Failure 25 25
Low Blood Pressure/ Hypotension 23 23
Increased Respiratory Rate 23 23
Loss of consciousness 22 22
Chest Pain 21 21
Apnea 20 20
Unspecified Eye / Vision Problem 18 18
Tachycardia 18 18
Pulmonary Dysfunction 16 16
Respiratory Acidosis 15 15
Stroke/CVA 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jan-16-2025
2 Baxter Healthcare Corporation I Oct-22-2024
3 Baxter Healthcare Corporation I Jun-26-2024
4 Baxter Healthcare Corporation I Feb-24-2023
5 Breas Medical, Inc. II Apr-15-2022
6 Covidien I Aug-02-2024
7 Covidien Llc I Dec-09-2021
8 Covidien Llc II Nov-06-2020
9 Draeger Medical, Inc. I Aug-18-2023
10 Draeger Medical, Inc. I Jul-08-2023
11 Draeger Medical, Inc. I Feb-24-2023
12 Draeger Medical, Inc. II Apr-04-2022
13 Draeger Medical, Inc. II Oct-14-2021
14 Draeger Medical, Inc. II May-28-2021
15 GE Healthcare, LLC I Jun-06-2022
16 GE Healthcare, LLC II Aug-24-2020
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, Inc. I Sep-20-2023
25 Hamilton Medical, Inc. I Jul-21-2023
26 Hill-Rom Manufacturing, Inc. II Nov-24-2020
27 Medtronic formerly Covidien I Apr-25-2022
28 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
29 Percussionaire Corporation I Jan-17-2024
30 Percussionaire Corporation I Jan-17-2024
31 Percussionaire Corporation II Nov-07-2023
32 Philips Respironics, Inc. I Nov-13-2024
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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