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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
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
  1.  K232836  Family of DIMAR DMAX NIV masks
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 20336 20336
2025 2759 2759

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 10786 10786
Output Problem 10746 10746
Circuit Failure 5945 5945
Battery Problem 4990 4990
Failure to Run on Battery 4341 4341
Electrical /Electronic Property Problem 4324 4324
Failure to Recalibrate 4043 4043
No Display/Image 3922 3922
Defective Component 3832 3832
Gas/Air Leak 2556 2556
Failure to Power Up 2524 2524
Degraded 2260 2260
Display or Visual Feedback Problem 2253 2253
Failure of Device to Self-Test 2249 2249
Failure to Calibrate 2098 2098
Improper Flow or Infusion 1832 1832
Insufficient Flow or Under Infusion 1827 1827
Failure to Charge 1798 1798
Unexpected Shutdown 1553 1553
Protective Measures Problem 1520 1520
Insufficient Information 1448 1448
Contamination 1374 1374
Power Problem 1298 1298
Infusion or Flow Problem 1248 1248
Failure to Deliver 1094 1094
No Flow 1069 1069
Decrease in Pressure 1064 1064
Leak/Splash 1012 1012
Gas Output Problem 949 949
Pressure Problem 784 784
Device Displays Incorrect Message 745 745
Complete Loss of Power 658 658
Therapeutic or Diagnostic Output Failure 565 565
Adverse Event Without Identified Device or Use Problem 512 512
Calibration Problem 496 496
Computer Software Problem 429 429
Connection Problem 395 395
Application Program Problem 395 395
Inadequate User Interface 390 390
Communication or Transmission Problem 374 374
Device Alarm System 331 331
Use of Device Problem 316 316
Increase in Pressure 297 297
Tidal Volume Fluctuations 265 265
Loose or Intermittent Connection 257 257
Unexpected Therapeutic Results 255 255
False Positive Result 244 244
Fracture 231 231
Contamination /Decontamination Problem 215 215
Incorrect, Inadequate or Imprecise Result or Readings 214 214

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74046 74046
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4179
Insufficient Information 1863 1863
Low Oxygen Saturation 924 924
No Information 556 556
Unspecified Respiratory Problem 535 535
Headache 357 357
No Known Impact Or Consequence To Patient 290 290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 278 278
Dizziness 256 256
Dyspnea 246 246
Respiratory Failure 169 169
Asthma 165 165
Cancer 159 159
Cardiac Arrest 136 136
Respiratory Insufficiency 132 132
Unspecified Kidney or Urinary Problem 131 131
Respiratory Tract Infection 128 128
Nausea 115 115
Skin Inflammation/ Irritation 99 99
Vomiting 92 92
Death 91 91
Cough 88 88
Inflammation 85 85
Ventilator Dependent 82 82
Hypoxia 76 76
Sore Throat 76 76
Hypersensitivity/Allergic reaction 73 73
Bradycardia 68 68
Respiratory Arrest 60 60
Unspecified Heart Problem 59 59
Pneumonia 51 51
Pneumothorax 46 46
Chronic Obstructive Pulmonary Disease (COPD) 46 46
Cyanosis 36 36
Unspecified Hepatic or Biliary Problem 35 35
Hypoventilation 29 29
Heart Failure/Congestive Heart Failure 27 27
Discomfort 27 27
Apnea 26 26
Increased Respiratory Rate 23 23
Low Blood Pressure/ Hypotension 23 23
Loss of consciousness 22 22
Chest Pain 21 21
Tachycardia 20 20
Unspecified Eye / Vision Problem 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-23-2025
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 Nov-13-2024
34 Philips Respironics, Inc. I Sep-05-2024
35 Philips Respironics, Inc. I Apr-17-2024
36 Philips Respironics, Inc. II Jan-04-2024
37 Philips Respironics, Inc. II Jul-07-2023
38 Philips Respironics, Inc. I Jun-02-2023
39 Philips Respironics, Inc. I Apr-03-2023
40 Philips Respironics, Inc. I Jan-06-2023
41 Philips Respironics, Inc. I Mar-18-2022
42 Philips Respironics, Inc. I Jan-22-2022
43 Philips Respironics, Inc. II Aug-13-2021
44 Philips Respironics, Inc. I Jul-15-2021
45 Philips Respironics, Inc. I Feb-15-2020
46 ResMed Ltd. I Oct-23-2023
47 Ventec Life Systems, Inc. I Feb-26-2025
48 Ventec Life Systems, Inc. I Feb-23-2024
49 Ventec Life Systems, Inc. II Jun-21-2021
50 Vyaire Medical II Jun-15-2023
51 Vyaire Medical I Feb-16-2022
52 Vyaire Medical II Mar-04-2020
53 ZOLL Medical Corporation I Jun-20-2024
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