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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
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
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 24957 24957
2024 13972 13972

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12112 12112
Output Problem 10176 10176
Circuit Failure 6814 6814
Failure to Recalibrate 4539 4539
Failure to Run on Battery 4096 4096
Battery Problem 4095 4129
No Display/Image 3969 3969
Defective Component 3820 3820
Electrical /Electronic Property Problem 3579 3579
Display or Visual Feedback Problem 2320 2320
Gas/Air Leak 2286 2286
Degraded 2222 2222
Failure to Power Up 2147 2147
Failure to Charge 1970 1986
Failure of Device to Self-Test 1910 1910
Failure to Calibrate 1907 2173
Protective Measures Problem 1839 1878
Improper Flow or Infusion 1800 1800
Insufficient Information 1403 1403
Unexpected Shutdown 1401 1401
Contamination 1369 1369
Infusion or Flow Problem 1270 1270
Insufficient Flow or Under Infusion 1209 1209
No Flow 1179 1179
Failure to Deliver 1144 1144
Power Problem 1137 1179
Leak/Splash 1050 1050
Decrease in Pressure 1022 1022
Device Displays Incorrect Message 939 939
Gas Output Problem 879 879
Pressure Problem 830 830
Therapeutic or Diagnostic Output Failure 714 714
Calibration Problem 708 708
Complete Loss of Power 612 612
Application Program Problem 555 555
Adverse Event Without Identified Device or Use Problem 537 537
Computer Software Problem 479 479
Incorrect, Inadequate or Imprecise Result or Readings 478 478
Inadequate User Interface 446 450
Device Alarm System 407 407
Communication or Transmission Problem 402 402
Connection Problem 394 394
Use of Device Problem 369 369
Tidal Volume Fluctuations 297 297
Increase in Pressure 296 296
Loose or Intermittent Connection 230 230
False Positive Result 225 225
Contamination /Decontamination Problem 219 219
Excess Flow or Over-Infusion 215 215
Peeled/Delaminated 214 214

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65250 65250
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1758 1758
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 960 960
No Information 865 865
Unspecified Respiratory Problem 515 515
Headache 344 344
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 273 273
Dizziness 247 247
Dyspnea 240 240
Death 184 184
Respiratory Failure 164 164
Asthma 161 161
Cancer 154 154
Cardiac Arrest 132 132
Unspecified Kidney or Urinary Problem 129 129
Respiratory Tract Infection 128 128
Respiratory Insufficiency 125 125
Nausea 111 111
Skin Inflammation/ Irritation 96 96
Vomiting 90 90
Cough 86 86
Ventilator Dependent 81 81
Inflammation 80 80
Sore Throat 76 76
Hypoxia 71 71
Hypersensitivity/Allergic reaction 71 71
Bradycardia 69 69
No Code Available 66 66
Unspecified Heart Problem 58 58
Pneumothorax 52 52
Pneumonia 50 50
Respiratory Arrest 48 48
Chronic Obstructive Pulmonary Disease (COPD) 44 44
Cyanosis 39 39
Unspecified Hepatic or Biliary Problem 34 34
Hypoventilation 31 31
Low Blood Pressure/ Hypotension 26 26
Increased Respiratory Rate 25 25
Discomfort 25 25
Heart Failure/Congestive Heart Failure 24 24
Loss of consciousness 23 23
Chest Pain 21 21
Tachycardia 21 21
Respiratory Distress 20 20
Apnea 19 19
Patient Problem/Medical Problem 18 18
Pulmonary Dysfunction 17 17

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