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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
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 6
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
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
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 16055 16055
2017 14451 14451
2018 9848 9848
2019 9099 9501
2020 11097 11097
2021 8664 8664

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 10146 10146
Device Operates Differently Than Expected 7171 7171
Mechanical Problem 6299 6299
No Display/Image 4118 4118
Battery Problem 4009 4043
Device Inoperable 3697 3697
Circuit Failure 3516 3516
Failure to Charge 2911 2927
Output Problem 2863 2863
Failure to Calibrate 2814 3080
Failure to Recalibrate 2487 2487
Device Operational Issue 2311 2311
Failure to Power Up 1692 1692
Incorrect Or Inadequate Test Results 1637 1637
Protective Measures Problem 1421 1460
Failure of Device to Self-Test 1384 1384
Appropriate Term/Code Not Available 1261 1261
Power Problem 1032 1074
Display or Visual Feedback Problem 926 926
Device Alarm System 812 812
No Flow 763 763
Calibration Problem 755 755
Electrical /Electronic Property Problem 726 726
Erratic or Intermittent Display 685 685
Leak/Splash 676 676
Loss of Power 663 663
Pressure Problem 644 644
Insufficient Information 629 629
Infusion or Flow Problem 623 623
Failure to Deliver 601 601
Adverse Event Without Identified Device or Use Problem 599 599
Unexpected Shutdown 564 564
Improper Flow or Infusion 484 484
Incorrect, Inadequate or Imprecise Resultor Readings 479 479
Therapeutic or Diagnostic Output Failure 472 472
Tidal Volume Fluctuations 465 465
Break 461 461
Charging Problem 432 432
Thermal Decomposition of Device 396 396
Noise, Audible 394 394
Communication or Transmission Problem 383 383
Gas Output Problem 380 380
Application Program Problem 362 362
Inaccurate Delivery 355 355
Contamination 348 348
Defective Component 347 347
Device Stops Intermittently 315 315
Decrease in Pressure 297 297
Inadequate User Interface 292 296
Application Interface Becomes Non-Functional Or Program Exits Abnormally 267 267
Inappropriate or Unexpected Reset 266 267
Defective Device 261 261
Failure to Cycle 261 261
No Audible Alarm 252 252
Use of Device Problem 210 210
Aborted Charge 204 204
Volume Accuracy Problem 193 193
Reset Problem 192 192
Self-Activation or Keying 183 183
Computer Operating System Problem 175 175
Gas Leak 170 170
Premature Discharge of Battery 170 170
Device Sensing Problem 163 163
Smoking 156 156
Temperature Problem 152 152
Complete Loss of Power 150 150
No Pressure 149 149
Image Display Error/Artifact 146 146
Occlusion Within Device 145 145
Disconnection 144 144
Defective Alarm 136 136
Computer Software Problem 121 121
Overheating of Device 118 118
Ventilation Problem in Device Environment 113 113
Increase in Pressure 108 108
Operating System Becomes Nonfunctional 102 102
Device Emits Odor 100 100
Contamination /Decontamination Problem 96 96
Detachment of Device or Device Component 91 91
Degraded 89 89
Suction Problem 86 86
Poor Quality Image 85 85
Low Readings 82 82
Connection Problem 72 72
Failure to Read Input Signal 69 69
Failure to Run on Battery 64 64
High Readings 60 60
Air Leak 60 60
Loose or Intermittent Connection 58 58
Crack 55 55
Fire 54 54
Nonstandard Device 52 52
Obstruction of Flow 52 52
Failure To Run On AC/DC 50 50
Low Battery 50 50
Data Problem 48 48
Improper Device Output 46 46
Excess Flow or Over-Infusion 46 46
Failure to Sense 46 46
Failure to Shut Off 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 28556 28556
No Consequences Or Impact To Patient 20636 21037
No Clinical Signs, Symptoms or Conditions 9056 9056
No Known Impact Or Consequence To Patient 5851 5852
No Information 2595 2595
No Code Available 1098 1098
Low Oxygen Saturation 592 593
Death 565 565
Insufficient Information 524 524
Cardiac Arrest 89 89
Respiratory Distress 83 83
Bradycardia 59 59
Hypoxia 47 47
Cyanosis 40 40
Patient Problem/Medical Problem 38 38
Cardiopulmonary Arrest 36 36
Pneumothorax 35 35
Hypoventilation 34 34
Dyspnea 31 31
Injury 29 29
Low Blood Pressure/ Hypotension 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Respiratory Failure 22 22
Loss of consciousness 16 16
Apnea 14 14
Tachycardia 12 12
Burn(s) 12 12
Respiratory Acidosis 11 11
Respiratory Arrest 11 11
Increased Respiratory Rate 8 8
Stacking Breaths 8 8
Pneumonia 8 8
Unspecified Infection 7 7
Urinary Retention 6 6
Discomfort 5 5
Hyperventilation 5 5
Pain 5 5
Perforation 5 5
Aspiration/Inhalation 5 5
High Blood Pressure/ Hypertension 4 4
Decreased Respiratory Rate 4 4
Coma 4 4
Cognitive Changes 4 4
Lethargy 4 4
Vomiting 4 4
Respiratory Insufficiency 4 4
High Oxygen Saturation 4 4
Foreign Body In Patient 3 3
Burning Sensation 3 3
Ventricular Fibrillation 3 3
Anxiety 3 3
Ventilator Dependent 3 3
Confusion/ Disorientation 3 3
Necrosis 3 3
Adult Respiratory Distress Syndrome 3 3
Unspecified Respiratory Problem 3 3
Convulsion/Seizure 3 3
Ventricular Tachycardia 3 3
Sweating 3 3
Neurological Deficit/Dysfunction 3 3
Therapeutic Effects, Unexpected 3 3
Swelling 2 2
Septic Shock 2 2
Inflammation 2 2
Crushing Injury 2 2
Pulmonary Emphysema 2 2
Encephalopathy 2 2
Respiratory Alkalosis 2 2
Sedation 2 2
Extubate 2 2
Pressure Sores 2 2
Thrombosis/Thrombus 2 2
Bowel Perforation 2 2
Cough 2 2
Partial thickness (Second Degree) Burn 2 2
Vascular Dissection 2 2
Multiple Organ Failure 2 2
Bruise/Contusion 2 2
Arrhythmia 2 2
Stroke/CVA 2 2
Abnormal Blood Gases 2 2
Myocardial Infarction 2 2
Headache 2 2
Electric Shock 2 2
Distress 2 2
Complaint, Ill-Defined 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Therapeutic Response, Increased 2 2
Brain Injury 2 2
Tissue Damage 2 2
Pulmonary Edema 2 2
Premature Labor 2 2
Device Embedded In Tissue or Plaque 2 2
Arthralgia 1 1
Diabetic Ketoacidosis 1 1
Inadequate Osseointegration 1 1
Hematemesis 1 1
Salivary Hypersecretion 1 1
Nervous System Injury 1 1
Hydrocephalus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC I Dec-18-2018
2 Carefusion 211 Inc dba Carefusion I Jun-13-2016
3 Covidien LLC II Mar-27-2018
4 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
5 Covidien Llc II Nov-06-2020
6 Datex-Ohmeda, Inc. II Aug-08-2018
7 Datex-Ohmeda, Inc. II Jun-01-2018
8 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
9 Draeger Medical, Inc. II May-28-2021
10 Draeger Medical, Inc. II May-29-2018
11 Draeger Medical, Inc. I Aug-04-2016
12 Draeger Medical, Inc. I Feb-25-2016
13 Draeger Medical, Inc. I Feb-03-2016
14 GE Healthcare, LLC II Aug-24-2020
15 GE Healthcare, LLC II Dec-17-2019
16 GE Healthcare, LLC I Nov-30-2018
17 GE Medical Systems, LLC II Jan-21-2016
18 Getinge Group Logistics America, LLC II Oct-09-2020
19 Hamilton Medical AG I Jul-11-2019
20 Hamilton Medical AG II Aug-14-2018
21 Hamilton Medical AG II Apr-12-2018
22 Hamilton Medical, Inc. II Nov-28-2016
23 Hamilton Medical, Inc. II May-09-2016
24 Hill-Rom Manufacturing, Inc. II Nov-24-2020
25 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
26 Newport Medical Instruments Inc I Apr-10-2017
27 Philips Respironics II Mar-07-2016
28 Philips Respironics, Inc. II Aug-13-2021
29 Philips Respironics, Inc. I Jul-15-2021
30 Philips Respironics, Inc. I Feb-15-2020
31 Resmed Corporation II Feb-03-2016
32 Spacelabs Healthcare, Ltd. I Aug-10-2018
33 Ventec Life Systems, Inc. II Jun-21-2021
34 Vyaire Medical II Mar-04-2020
35 ZOLL Medical Corporation II Mar-01-2018
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