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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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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
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K232365  Vivo 45 LS
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 9622 9622

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11941 11941
Output Problem 9601 9601
Circuit Failure 6626 6626
Failure to Recalibrate 4446 4446
Failure to Run on Battery 3968 3968
Defective Component 3794 3794
Battery Problem 3749 3783
No Display/Image 3735 3735
Electrical /Electronic Property Problem 3229 3229
Display or Visual Feedback Problem 2252 2252
Gas/Air Leak 2123 2123
Failure to Power Up 1958 1958
Failure to Charge 1871 1887
Failure of Device to Self-Test 1855 1855
Protective Measures Problem 1838 1877
Degraded 1794 1794
Failure to Calibrate 1785 2051
Improper Flow or Infusion 1709 1709
Insufficient Information 1333 1333
Contamination 1317 1317
Unexpected Shutdown 1301 1301
Infusion or Flow Problem 1212 1212
No Flow 1112 1112
Failure to Deliver 1088 1088
Power Problem 1055 1097
Leak/Splash 1042 1042
Decrease in Pressure 990 990
Insufficient Flow or Under Infusion 949 949
Device Displays Incorrect Message 938 938
Gas Output Problem 830 830
Pressure Problem 804 804
Calibration Problem 701 701
Therapeutic or Diagnostic Output Failure 678 678
Complete Loss of Power 562 562
Application Program Problem 547 547
Adverse Event Without Identified Device or Use Problem 522 522
Incorrect, Inadequate or Imprecise Result or Readings 477 477
Computer Software Problem 470 470
Inadequate User Interface 443 447
Communication or Transmission Problem 396 396
Device Alarm System 396 396
Connection Problem 368 368
Use of Device Problem 362 362
Tidal Volume Fluctuations 290 290
Increase in Pressure 270 270
Loose or Intermittent Connection 220 220
Peeled/Delaminated 214 214
Contamination /Decontamination Problem 214 214
Excess Flow or Over-Infusion 213 213
Defective Device 209 209
False Positive Result 207 207
Premature Discharge of Battery 204 204
Reset Problem 204 204
Break 202 202
Appropriate Term/Code Not Available 191 191
Noise, Audible 189 189
Inaccurate Delivery 186 186
Obstruction of Flow 183 183
Alarm Not Visible 181 181
Medical Gas Supply Problem 177 177
Smoking 175 175
Temperature Problem 170 170
Charging Problem 168 168
Device Sensing Problem 166 166
Fracture 166 166
Defective Alarm 161 161
Failure to Conduct 159 159
Erratic or Intermittent Display 157 157
Detachment of Device or Device Component 150 150
Low Readings 148 148
Key or Button Unresponsive/not Working 140 140
Unexpected Therapeutic Results 139 139
Disconnection 137 137
No Pressure 128 128
Inappropriate or Unexpected Reset 118 119
No Audible Alarm 118 118
No Visual Prompts/Feedback 117 117
Inaccurate Flow Rate 113 113
Mechanical Jam 113 113
Incomplete or Inadequate Connection 108 108
Decreased Pump Speed 104 104
Loss of Power 100 100
Volume Accuracy Problem 100 100
Electrical Shorting 98 98
No Apparent Adverse Event 98 98
Intermittent Continuity 97 97
Intermittent Communication Failure 95 95
Failure to Read Input Signal 93 93
Failure to Sense 91 91
Failure to Cycle 87 87
Activation Failure 87 87
Device Handling Problem 87 87
Accessory Incompatible 83 83
Unintended Collision 79 79
Suction Problem 79 79
Application Program Freezes, Becomes Nonfunctional 77 77
No Tactile Prompts/Feedback 76 76
Overheating of Device 76 76
Computer Operating System Problem 75 75
Free or Unrestricted Flow 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61265 61265
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1695 1695
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 909 909
No Information 865 865
Unspecified Respiratory Problem 359 359
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 261 261
Headache 252 252
Dyspnea 235 235
Death 184 184
Respiratory Failure 158 158
Dizziness 158 158
Cardiac Arrest 128 128
Respiratory Insufficiency 124 124
Respiratory Tract Infection 110 110
Asthma 89 89
Cancer 89 89
Cough 85 85
Unspecified Kidney or Urinary Problem 81 81
Ventilator Dependent 80 80
Sore Throat 76 76
Nausea 71 71
Hypoxia 67 67
No Code Available 66 66
Bradycardia 62 62
Skin Inflammation/ Irritation 60 60
Pneumothorax 52 52
Vomiting 50 50
Hypersensitivity/Allergic reaction 45 45
Respiratory Arrest 45 45
Inflammation 43 43
Pneumonia 43 43
Cyanosis 39 39
Chronic Obstructive Pulmonary Disease (COPD) 37 37
Hypoventilation 30 30
Unspecified Heart Problem 30 30
Low Blood Pressure/ Hypotension 25 25
Increased Respiratory Rate 25 25
Discomfort 24 24
Loss of consciousness 23 23
Unspecified Hepatic or Biliary Problem 23 23
Tachycardia 20 20
Respiratory Distress 20 20
Chest Pain 20 20
Heart Failure/Congestive Heart Failure 19 19
Patient Problem/Medical Problem 18 18
Apnea 18 18
Cardiopulmonary Arrest 16 16
Unspecified Infection 16 16
Unspecified Eye / Vision Problem 16 16
Respiratory Acidosis 15 15
Pulmonary Dysfunction 14 14
Stroke/CVA 13 13
Abnormal Blood Gases 13 13
Injury 12 12
Epistaxis 11 11
Nodule 10 10
Anxiety 10 10
Liver Damage/Dysfunction 10 10
High Blood Pressure/ Hypertension 9 9
Hyperventilation 9 9
Renal Failure 9 9
Dry Eye(s) 8 8
Fatigue 8 8
Swelling/ Edema 8 8
Bronchitis 7 7
Rash 7 7
Pain 6 6
Burn(s) 6 6
Airway Obstruction 6 6
Urinary Retention 6 6
Overinflation of Lung 6 6
Bowel Perforation 6 6
Cardiovascular Insufficiency 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Sleep Dysfunction 5 5
Coma 5 5
Sinus Perforation 5 5
Adult Respiratory Distress Syndrome 5 5
Atrial Fibrillation 5 5
Bacterial Infection 5 5
Fever 5 5
Pulmonary Emphysema 5 5
Necrosis 5 5
Hemorrhage/Bleeding 5 5
Hemoptysis 4 4
Perforation 4 4
Encephalopathy 4 4
Fall 4 4
Aspiration/Inhalation 4 4
Viral Infection 4 4
Burning Sensation 4 4
Brain Injury 4 4
Confusion/ Disorientation 4 4
Electric Shock 4 4
Decreased Respiratory Rate 4 4
Asystole 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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