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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
  1.  K203449  F&P Visairo NIV Mask Range
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 2
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 10957 10957

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11998 11998
Output Problem 9772 9772
Circuit Failure 6686 6686
Failure to Recalibrate 4493 4493
Failure to Run on Battery 4005 4005
Battery Problem 3811 3845
No Display/Image 3807 3807
Defective Component 3801 3801
Electrical /Electronic Property Problem 3359 3359
Display or Visual Feedback Problem 2273 2273
Gas/Air Leak 2178 2178
Failure to Power Up 2005 2005
Degraded 1919 1919
Failure to Charge 1879 1895
Failure of Device to Self-Test 1873 1873
Protective Measures Problem 1838 1877
Failure to Calibrate 1826 2092
Improper Flow or Infusion 1730 1730
Insufficient Information 1353 1353
Contamination 1334 1334
Unexpected Shutdown 1330 1330
Infusion or Flow Problem 1231 1231
No Flow 1131 1131
Failure to Deliver 1117 1117
Power Problem 1080 1122
Leak/Splash 1043 1043
Insufficient Flow or Under Infusion 1026 1026
Decrease in Pressure 996 996
Device Displays Incorrect Message 939 939
Gas Output Problem 841 841
Pressure Problem 808 808
Calibration Problem 703 703
Therapeutic or Diagnostic Output Failure 690 690
Complete Loss of Power 581 581
Application Program Problem 547 547
Adverse Event Without Identified Device or Use Problem 527 527
Incorrect, Inadequate or Imprecise Result or Readings 477 477
Computer Software Problem 473 473
Inadequate User Interface 444 448
Device Alarm System 403 403
Communication or Transmission Problem 399 399
Connection Problem 379 379
Use of Device Problem 365 365
Tidal Volume Fluctuations 295 295
Increase in Pressure 278 278
Loose or Intermittent Connection 221 221
Contamination /Decontamination Problem 215 215
Peeled/Delaminated 214 214
Excess Flow or Over-Infusion 213 213
False Positive Result 212 212
Defective Device 210 210
Reset Problem 207 207
Premature Discharge of Battery 206 206
Break 202 202
Appropriate Term/Code Not Available 193 193
Inaccurate Delivery 191 191
Noise, Audible 191 191
Obstruction of Flow 184 184
Alarm Not Visible 182 182
Medical Gas Supply Problem 177 177
Smoking 176 176
Device Sensing Problem 172 172
Temperature Problem 171 171
Fracture 170 170
Charging Problem 168 168
Defective Alarm 166 166
Erratic or Intermittent Display 164 164
Failure to Conduct 160 160
Unexpected Therapeutic Results 154 154
Low Readings 153 153
Detachment of Device or Device Component 151 151
Key or Button Unresponsive/not Working 143 143
Disconnection 140 140
No Pressure 128 128
No Visual Prompts/Feedback 124 124
Inappropriate or Unexpected Reset 119 120
No Audible Alarm 118 118
Inaccurate Flow Rate 117 117
Mechanical Jam 114 114
Decreased Pump Speed 108 108
Incomplete or Inadequate Connection 108 108
Volume Accuracy Problem 101 101
No Apparent Adverse Event 101 101
Loss of Power 100 100
Electrical Shorting 98 98
Intermittent Continuity 97 97
Intermittent Communication Failure 97 97
Failure to Read Input Signal 95 95
Failure to Sense 92 92
Device Handling Problem 89 89
No Device Output 88 88
Failure to Cycle 87 87
Activation Failure 87 87
Accessory Incompatible 83 83
Computer Operating System Problem 81 81
Application Program Freezes, Becomes Nonfunctional 80 80
Suction Problem 79 79
Unintended Collision 79 79
Overheating of Device 78 78
No Tactile Prompts/Feedback 77 77

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62444 62444
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1713 1713
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 930 930
No Information 865 865
Unspecified Respiratory Problem 446 446
Headache 305 305
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 264 264
Dyspnea 236 236
Dizziness 209 209
Death 184 184
Respiratory Failure 162 162
Asthma 130 130
Cardiac Arrest 130 130
Respiratory Insufficiency 124 124
Respiratory Tract Infection 120 120
Cancer 114 114
Unspecified Kidney or Urinary Problem 99 99
Nausea 93 93
Cough 86 86
Ventilator Dependent 80 80
Sore Throat 76 76
Skin Inflammation/ Irritation 74 74
Vomiting 72 72
Hypoxia 69 69
No Code Available 66 66
Bradycardia 64 64
Inflammation 62 62
Hypersensitivity/Allergic reaction 57 57
Pneumothorax 52 52
Pneumonia 45 45
Respiratory Arrest 45 45
Unspecified Heart Problem 41 41
Cyanosis 39 39
Chronic Obstructive Pulmonary Disease (COPD) 38 38
Hypoventilation 31 31
Unspecified Hepatic or Biliary Problem 28 28
Low Blood Pressure/ Hypotension 25 25
Discomfort 25 25
Increased Respiratory Rate 25 25
Loss of consciousness 23 23
Chest Pain 21 21
Heart Failure/Congestive Heart Failure 21 21
Respiratory Distress 20 20
Tachycardia 20 20
Apnea 18 18
Patient Problem/Medical Problem 18 18
Pulmonary Dysfunction 17 17
Unspecified Infection 16 16
Cardiopulmonary Arrest 16 16
Unspecified Eye / Vision Problem 16 16
Respiratory Acidosis 15 15
Stroke/CVA 14 14
Abnormal Blood Gases 13 13
Liver Damage/Dysfunction 12 12
Injury 12 12
Epistaxis 11 11
Nodule 10 10
Anxiety 10 10
High Blood Pressure/ Hypertension 10 10
Hyperventilation 9 9
Bronchitis 9 9
Renal Failure 9 9
Dry Eye(s) 8 8
Fatigue 8 8
Swelling/ Edema 8 8
Cardiovascular Insufficiency 7 7
Convulsion/Seizure 7 7
Rash 7 7
Pain 6 6
Bacterial Infection 6 6
Burn(s) 6 6
Airway Obstruction 6 6
Urinary Retention 6 6
Overinflation of Lung 6 6
Bowel Perforation 6 6
Thrombosis/Thrombus 5 5
Sinus Perforation 5 5
Sleep Dysfunction 5 5
Coma 5 5
Adult Respiratory Distress Syndrome 5 5
Atrial Fibrillation 5 5
Pulmonary Emphysema 5 5
Necrosis 5 5
Fever 5 5
Hemorrhage/Bleeding 5 5
Hemoptysis 4 4
Perforation 4 4
Encephalopathy 4 4
Fall 4 4
Aspiration/Inhalation 4 4
Confusion/ Disorientation 4 4
Electric Shock 4 4
Decreased Respiratory Rate 4 4
Viral Infection 4 4
Brain Injury 4 4
Burning Sensation 4 4
Asystole 4 4

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