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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
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
  1.  K231778  Nihon Kohden NKV-550 Series Ventilator System
OCONNELL REGULATORY CONSULTANTS, INC.
  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 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 8134 8134

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11884 11884
Output Problem 9400 9400
Circuit Failure 6568 6568
Failure to Recalibrate 4394 4394
Failure to Run on Battery 3936 3936
Defective Component 3790 3790
Battery Problem 3717 3751
No Display/Image 3660 3660
Electrical /Electronic Property Problem 3081 3081
Display or Visual Feedback Problem 2232 2232
Gas/Air Leak 2061 2061
Failure to Power Up 1897 1897
Failure to Charge 1864 1880
Failure of Device to Self-Test 1841 1841
Protective Measures Problem 1838 1877
Failure to Calibrate 1739 2005
Improper Flow or Infusion 1683 1683
Degraded 1621 1621
Insufficient Information 1299 1299
Contamination 1297 1297
Unexpected Shutdown 1268 1268
Infusion or Flow Problem 1191 1191
No Flow 1096 1096
Failure to Deliver 1059 1059
Leak/Splash 1039 1039
Power Problem 1028 1070
Decrease in Pressure 982 982
Device Displays Incorrect Message 938 938
Insufficient Flow or Under Infusion 857 857
Gas Output Problem 800 800
Pressure Problem 796 796
Calibration Problem 698 698
Therapeutic or Diagnostic Output Failure 664 664
Application Program Problem 545 545
Complete Loss of Power 538 538
Adverse Event Without Identified Device or Use Problem 509 509
Incorrect, Inadequate or Imprecise Result or Readings 473 473
Computer Software Problem 469 469
Inadequate User Interface 441 445
Communication or Transmission Problem 389 389
Device Alarm System 388 388
Use of Device Problem 361 361
Connection Problem 360 360
Tidal Volume Fluctuations 285 285
Increase in Pressure 266 266
Excess Flow or Over-Infusion 213 213
Contamination /Decontamination Problem 213 213
Loose or Intermittent Connection 211 211
Peeled/Delaminated 211 211
Defective Device 209 209
Reset Problem 202 202
False Positive Result 202 202
Break 201 201
Premature Discharge of Battery 200 200
Appropriate Term/Code Not Available 189 189
Noise, Audible 189 189
Inaccurate Delivery 184 184
Obstruction of Flow 182 182
Alarm Not Visible 179 179
Medical Gas Supply Problem 177 177
Smoking 175 175
Temperature Problem 169 169
Fracture 166 166
Charging Problem 165 165
Device Sensing Problem 160 160
Defective Alarm 160 160
Failure to Conduct 159 159
Erratic or Intermittent Display 152 152
Detachment of Device or Device Component 148 148
Low Readings 140 140
Disconnection 137 137
Key or Button Unresponsive/not Working 137 137
No Pressure 127 127
Unexpected Therapeutic Results 125 125
Inappropriate or Unexpected Reset 118 119
No Audible Alarm 117 117
No Visual Prompts/Feedback 115 115
Mechanical Jam 109 109
Inaccurate Flow Rate 108 108
Incomplete or Inadequate Connection 108 108
Loss of Power 100 100
Volume Accuracy Problem 99 99
Electrical Shorting 98 98
No Apparent Adverse Event 97 97
Decreased Pump Speed 96 96
Intermittent Continuity 94 94
Failure to Read Input Signal 90 90
Intermittent Communication Failure 90 90
Device Handling Problem 87 87
Failure to Sense 87 87
Failure to Cycle 87 87
Activation Failure 86 86
Accessory Incompatible 82 82
Suction Problem 79 79
Unintended Collision 78 78
Application Program Freezes, Becomes Nonfunctional 76 76
Overheating of Device 74 74
Computer Operating System Problem 73 73
No Tactile Prompts/Feedback 73 73
Free or Unrestricted Flow 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59984 59984
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1665 1665
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 891 891
No Information 865 865
Unspecified Respiratory Problem 270 270
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 259 259
Dyspnea 227 227
Headache 193 193
Death 184 184
Respiratory Failure 154 154
Cardiac Arrest 128 128
Respiratory Insufficiency 121 121
Dizziness 98 98
Respiratory Tract Infection 91 91
Cough 83 83
Ventilator Dependent 79 79
Sore Throat 76 76
No Code Available 66 66
Hypoxia 65 65
Bradycardia 62 62
Pneumothorax 51 51
Nausea 50 50
Asthma 49 49
Respiratory Arrest 43 43
Unspecified Kidney or Urinary Problem 40 40
Cancer 40 40
Cyanosis 39 39
Skin Inflammation/ Irritation 33 33
Pneumonia 32 32
Hypoventilation 29 29
Chronic Obstructive Pulmonary Disease (COPD) 29 29
Vomiting 28 28
Hypersensitivity/Allergic reaction 27 27
Inflammation 27 27
Low Blood Pressure/ Hypotension 24 24
Discomfort 24 24
Increased Respiratory Rate 24 24
Loss of consciousness 23 23
Tachycardia 20 20
Respiratory Distress 20 20
Chest Pain 19 19
Apnea 18 18
Patient Problem/Medical Problem 18 18
Unspecified Heart Problem 18 18
Heart Failure/Congestive Heart Failure 16 16
Unspecified Eye / Vision Problem 16 16
Cardiopulmonary Arrest 16 16
Unspecified Infection 16 16
Respiratory Acidosis 15 15
Unspecified Hepatic or Biliary Problem 14 14
Stroke/CVA 13 13
Abnormal Blood Gases 12 12
Injury 12 12
Epistaxis 11 11
Nodule 10 10
Anxiety 10 10
Liver Damage/Dysfunction 9 9
High Blood Pressure/ Hypertension 8 8
Hyperventilation 8 8
Dry Eye(s) 8 8
Fatigue 8 8
Renal Failure 8 8
Swelling/ Edema 8 8
Pulmonary Dysfunction 7 7
Rash 7 7
Pain 6 6
Airway Obstruction 6 6
Burn(s) 6 6
Urinary Retention 6 6
Overinflation of Lung 6 6
Bowel Perforation 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Sleep Dysfunction 5 5
Coma 5 5
Sinus Perforation 5 5
Bronchitis 5 5
Adult Respiratory Distress Syndrome 5 5
Fever 5 5
Hemorrhage/Bleeding 5 5
Necrosis 5 5
Hemoptysis 4 4
Perforation 4 4
Fall 4 4
Pulmonary Emphysema 4 4
Encephalopathy 4 4
Atrial Fibrillation 4 4
Aspiration/Inhalation 4 4
Burning Sensation 4 4
Brain Injury 4 4
Partial thickness (Second Degree) Burn 4 4
Confusion/ Disorientation 4 4
Electric Shock 4 4
Asystole 4 4
Cardiovascular Insufficiency 4 4
Speech Disorder 4 4
Dry Mouth 4 4

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