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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
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 24955 24955
2024 2185 2185

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11624 11624
Output Problem 8798 8798
Circuit Failure 6248 6248
Failure to Recalibrate 4191 4191
Failure to Run on Battery 3771 3771
Battery Problem 3519 3553
No Display/Image 3428 3428
Defective Component 3184 3184
Electrical /Electronic Property Problem 2560 2560
Display or Visual Feedback Problem 2086 2086
Failure to Charge 1841 1857
Protective Measures Problem 1832 1871
Failure of Device to Self-Test 1777 1777
Gas/Air Leak 1760 1760
Failure to Power Up 1736 1736
Failure to Calibrate 1608 1874
Improper Flow or Infusion 1558 1558
Degraded 1506 1506
Contamination 1233 1233
Unexpected Shutdown 1161 1161
Infusion or Flow Problem 1135 1135
Insufficient Information 1123 1123
No Flow 1051 1051
Failure to Deliver 977 977
Leak/Splash 939 939
Device Displays Incorrect Message 938 938
Decrease in Pressure 931 931
Power Problem 926 968
Pressure Problem 762 762
Gas Output Problem 721 721
Calibration Problem 669 669
Therapeutic or Diagnostic Output Failure 641 641
Insufficient Flow or Under Infusion 603 603
Application Program Problem 534 534
Complete Loss of Power 468 468
Incorrect, Inadequate or Imprecise Result or Readings 467 467
Adverse Event Without Identified Device or Use Problem 463 463
Inadequate User Interface 439 443
Computer Software Problem 430 430
Device Alarm System 360 360
Use of Device Problem 348 348
Communication or Transmission Problem 343 343
Connection Problem 303 303
Tidal Volume Fluctuations 272 272
Increase in Pressure 230 230
Peeled/Delaminated 208 208
Contamination /Decontamination Problem 207 207
Defective Device 205 205
Premature Discharge of Battery 199 199
Excess Flow or Over-Infusion 198 198
Reset Problem 197 197
Appropriate Term/Code Not Available 178 178
Noise, Audible 177 177
Medical Gas Supply Problem 175 175
Break 175 175
False Positive Result 173 173
Obstruction of Flow 172 172
Loose or Intermittent Connection 169 169
Smoking 169 169
Temperature Problem 165 165
Inaccurate Delivery 163 163
Charging Problem 155 155
Defective Alarm 154 154
Fracture 152 152
Failure to Conduct 142 142
Detachment of Device or Device Component 141 141
Device Sensing Problem 137 137
Erratic or Intermittent Display 131 131
Low Readings 128 128
Alarm Not Visible 127 127
Disconnection 126 126
No Pressure 122 122
No Visual Prompts/Feedback 112 112
No Audible Alarm 111 111
Key or Button Unresponsive/not Working 105 105
Incomplete or Inadequate Connection 102 102
Inappropriate or Unexpected Reset 101 102
Loss of Power 100 100
Electrical Shorting 95 95
Volume Accuracy Problem 91 91
Unexpected Therapeutic Results 87 87
Mechanical Jam 85 85
Failure to Cycle 83 83
Decreased Pump Speed 82 82
Accessory Incompatible 79 79
Intermittent Communication Failure 79 79
Inaccurate Flow Rate 78 78
Unintended Collision 75 75
Failure to Read Input Signal 75 75
No Apparent Adverse Event 75 75
Device Handling Problem 75 75
Suction Problem 75 75
Intermittent Continuity 74 74
Operating System Becomes Nonfunctional 68 68
Free or Unrestricted Flow 68 68
Overheating of Device 67 67
Tactile Prompts/Feedback 67 67
Application Program Freezes, Becomes Nonfunctional 65 65
Computer Operating System Problem 65 65
Activation Problem 64 64

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54299 54299
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1601 1601
No Known Impact Or Consequence To Patient 1036 1037
No Information 865 865
Low Oxygen Saturation 838 838
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 240 240
Dyspnea 213 213
Unspecified Respiratory Problem 193 193
Death 184 184
Headache 156 156
Respiratory Failure 145 145
Cardiac Arrest 122 122
Respiratory Insufficiency 121 121
Respiratory Tract Infection 83 83
Cough 82 82
Ventilator Dependent 78 78
Sore Throat 76 76
No Code Available 66 66
Dizziness 62 62
Bradycardia 61 61
Hypoxia 59 59
Nausea 44 44
Pneumothorax 44 44
Respiratory Arrest 38 38
Cyanosis 34 34
Hypoventilation 29 29
Pneumonia 28 28
Cancer 24 24
Loss of consciousness 23 23
Low Blood Pressure/ Hypotension 23 23
Increased Respiratory Rate 22 22
Skin Inflammation/ Irritation 22 22
Discomfort 21 21
Vomiting 20 20
Respiratory Distress 20 20
Asthma 19 19
Chest Pain 18 18
Tachycardia 18 18
Patient Problem/Medical Problem 18 18
Unspecified Kidney or Urinary Problem 17 17
Chronic Obstructive Pulmonary Disease (COPD) 16 16
Cardiopulmonary Arrest 16 16
Unspecified Infection 16 16
Inflammation 16 16
Apnea 15 15
Respiratory Acidosis 15 15
Unspecified Eye / Vision Problem 14 14
Heart Failure/Congestive Heart Failure 12 12
Unspecified Heart Problem 12 12
Injury 12 12
Hypersensitivity/Allergic reaction 12 12
Epistaxis 11 11
Abnormal Blood Gases 10 10
Anxiety 9 9
Dry Eye(s) 8 8
Fatigue 8 8
Hyperventilation 8 8
Nodule 8 8
Swelling/ Edema 8 8
High Blood Pressure/ Hypertension 7 7
Renal Failure 7 7
Rash 7 7
Pain 6 6
Urinary Retention 6 6
Bowel Perforation 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Unspecified Hepatic or Biliary Problem 5 5
Sleep Dysfunction 5 5
Coma 5 5
Necrosis 5 5
Fever 5 5
Burn(s) 5 5
Stroke/CVA 5 5
Aspiration/Inhalation 4 4
Airway Obstruction 4 4
Pulmonary Emphysema 4 4
Encephalopathy 4 4
Perforation 4 4
Hemoptysis 4 4
Fall 4 4
Sinus Perforation 4 4
Brain Injury 4 4
Burning Sensation 4 4
Partial thickness (Second Degree) Burn 4 4
Confusion/ Disorientation 4 4
Electric Shock 4 4
Dry Mouth 4 4
Wheezing 4 4
Asystole 4 4
Speech Disorder 4 4
Taste Disorder 3 3
Hydrocephalus 3 3
Eye Infections 3 3
Unspecified Gastrointestinal Problem 3 3
Decreased Respiratory Rate 3 3
Choking 3 3
Abdominal Distention 3 3

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. II Jan-04-2024
30 Philips Respironics, Inc. II Jul-07-2023
31 Philips Respironics, Inc. I Jun-02-2023
32 Philips Respironics, Inc. I Apr-03-2023
33 Philips Respironics, Inc. I Jan-06-2023
34 Philips Respironics, Inc. I Mar-18-2022
35 Philips Respironics, Inc. I Jan-22-2022
36 Philips Respironics, Inc. II Aug-13-2021
37 Philips Respironics, Inc. I Jul-15-2021
38 Philips Respironics, Inc. I Feb-15-2020
39 ResMed Ltd. I Oct-23-2023
40 Ventec Life Systems, Inc. I Feb-23-2024
41 Ventec Life Systems, Inc. II Jun-21-2021
42 Vyaire Medical II Jun-15-2023
43 Vyaire Medical I Feb-16-2022
44 Vyaire Medical II Mar-04-2020
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