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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
Regulation Description Continuous ventilator.
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 6
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 6
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 2
RESMED
  SUBSTANTIALLY EQUIVALENT 1
RESMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  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 3398 3398

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 10063 10063
Device Operates Differently Than Expected 7171 7171
Mechanical Problem 5328 5328
No Display/Image 3940 3940
Device Inoperable 3697 3697
Battery Problem 3691 3725
Circuit Failure 3058 3058
Failure to Charge 2755 2771
Failure to Calibrate 2746 3012
Device Operational Issue 2311 2311
Failure to Recalibrate 2167 2167
Output Problem 1807 1807
Incorrect Or Inadequate Test Results 1637 1637
Failure to Power Up 1595 1595
Appropriate Term/Code Not Available 1247 1247
Protective Measures Problem 1219 1258
Failure of Device to Self-Test 1198 1198
Power Problem 972 1014
Device Alarm System 790 790
Display or Visual Feedback Problem 741 741
No Flow 712 712
Calibration Problem 703 703
Erratic or Intermittent Display 680 680
Loss of Power 662 662
Electrical /Electronic Property Problem 622 622
Leak/Splash 600 600
Adverse Event Without Identified Device or Use Problem 575 575
Pressure Problem 560 560
Insufficient Information 540 540
Failure to Deliver 530 530
Incorrect, Inadequate or Imprecise Resultor Readings 465 465
Unexpected Shutdown 459 459
Infusion or Flow Problem 454 454
Break 453 453
Tidal Volume Fluctuations 450 450
Therapeutic or Diagnostic Output Failure 431 431
Charging Problem 427 427
Improper Flow or Infusion 426 426
Thermal Decomposition of Device 394 394
Noise, Audible 378 378
Communication or Transmission Problem 368 368
Application Program Problem 347 347
Inaccurate Delivery 344 344
Defective Component 324 324
Gas Output Problem 316 316
Device Stops Intermittently 315 315
Contamination 295 295
Application Interface Becomes Non-Functional Or Program Exits Abnormally 267 267
Failure to Cycle 259 259
Inappropriate or Unexpected Reset 257 258
Defective Device 252 252
No Audible Alarm 250 250
Inadequate User Interface 237 241
Decrease in Pressure 234 234
Aborted Charge 204 204
Use of Device Problem 187 187
Volume Accuracy Problem 184 184
Self-Activation or Keying 180 180
Computer Operating System Problem 170 170
Reset Problem 157 157
Device Sensing Problem 149 149
Premature Discharge of Battery 148 148
No Pressure 147 147
Image Display Error/Artifact 145 145
Occlusion Within Device 145 145
Smoking 142 142
Disconnection 138 138
Temperature Problem 134 134
Gas Leak 126 126
Complete Loss of Power 125 125
Defective Alarm 122 122
Overheating of Device 114 114
Ventilation Problem in Device Environment 112 112
Computer Software Problem 106 106
Device Emits Odor 100 100
Operating System Becomes Nonfunctional 93 93
Increase in Pressure 91 91
Suction Problem 86 86
Poor Quality Image 85 85
Detachment of Device or Device Component 82 82
Contamination /Decontamination Problem 77 77
Low Readings 76 76
Connection Problem 70 70
Failure to Read Input Signal 65 65
Degraded 65 65
Air Leak 60 60
High Readings 59 59
Loose or Intermittent Connection 56 56
Crack 54 54
Fire 52 52
Failure To Run On AC/DC 50 50
Low Battery 50 50
Nonstandard Device 49 49
Obstruction of Flow 48 48
Failure to Run on Battery 47 47
Improper Device Output 46 46
Data Problem 46 46
Excess Flow or Over-Infusion 46 46
Sticking 45 45
Failure to Shut Off 44 44

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 Known Impact Or Consequence To Patient 5851 5852
No Clinical Signs, Symptoms or Conditions 4188 4188
No Information 2595 2595
No Code Available 1098 1098
Death 565 565
Low Oxygen Saturation 527 528
Insufficient Information 227 227
Respiratory Distress 83 83
Cardiac Arrest 70 70
Bradycardia 52 52
Hypoxia 42 42
Cyanosis 39 39
Patient Problem/Medical Problem 38 38
Cardiopulmonary Arrest 36 36
Hypoventilation 31 31
Pneumothorax 31 31
Injury 29 29
Dyspnea 26 26
Low Blood Pressure/ Hypotension 22 22
Respiratory Failure 21 21
Loss of consciousness 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Tachycardia 12 12
Apnea 12 12
Respiratory Acidosis 11 11
Burn(s) 11 11
Respiratory Arrest 9 9
Stacking Breaths 8 8
Unspecified Infection 6 6
Pneumonia 6 6
Urinary Retention 6 6
Increased Respiratory Rate 5 5
Hyperventilation 5 5
Pain 5 5
Perforation 5 5
High Blood Pressure/ Hypertension 4 4
Aspiration/Inhalation 4 4
Lethargy 4 4
Decreased Respiratory Rate 4 4
Coma 4 4
High Oxygen Saturation 4 4
Vomiting 4 4
Discomfort 4 4
Burning Sensation 3 3
Ventricular Fibrillation 3 3
Adult Respiratory Distress Syndrome 3 3
Ventricular Tachycardia 3 3
Sweating 3 3
Cognitive Changes 3 3
Neurological Deficit/Dysfunction 3 3
Therapeutic Effects, Unexpected 3 3
Septic Shock 2 2
Swelling 2 2
Crushing Injury 2 2
Pulmonary Emphysema 2 2
Encephalopathy 2 2
Partial thickness (Second Degree) Burn 2 2
Vascular Dissection 2 2
Multiple Organ Failure 2 2
Pressure Sores 2 2
Sedation 2 2
Extubate 2 2
Respiratory Alkalosis 2 2
Bruise/Contusion 2 2
Arrhythmia 2 2
Abnormal Blood Gases 2 2
Myocardial Infarction 2 2
Pulmonary Edema 2 2
Tissue Damage 2 2
Brain Injury 2 2
Complaint, Ill-Defined 2 2
Therapeutic Response, Increased 2 2
Anxiety 2 2
Distress 2 2
Premature Labor 2 2
Ventilator Dependent 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Nervous System Injury 1 1
Salivary Hypersecretion 1 1
Hydrocephalus 1 1
Loss Of Pulse 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Weight Changes 1 1
Overinflation of Lung 1 1
Reaction 1 1
Arthralgia 1 1
Diabetic Ketoacidosis 1 1
Inadequate Osseointegration 1 1
Convulsion, Clonic 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Stroke/CVA 1 1
Chest Pain 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-29-2018
10 Draeger Medical, Inc. I Aug-04-2016
11 Draeger Medical, Inc. I Feb-25-2016
12 Draeger Medical, Inc. I Feb-03-2016
13 GE Healthcare, LLC II Aug-24-2020
14 GE Healthcare, LLC II Dec-17-2019
15 GE Healthcare, LLC I Nov-30-2018
16 GE Medical Systems, LLC II Jan-21-2016
17 Getinge Group Logistics America, LLC II Oct-09-2020
18 Hamilton Medical AG I Jul-11-2019
19 Hamilton Medical AG II Aug-14-2018
20 Hamilton Medical AG II Apr-12-2018
21 Hamilton Medical, Inc. II Nov-28-2016
22 Hamilton Medical, Inc. II May-09-2016
23 Hill-Rom Manufacturing, Inc. II Nov-24-2020
24 Newport Medical Instruments Inc I Apr-10-2017
25 Philips Respironics II Mar-07-2016
26 Philips Respironics, Inc. I Feb-15-2020
27 Resmed Corporation II Feb-03-2016
28 Spacelabs Healthcare, Ltd. I Aug-10-2018
29 Vyaire Medical II Mar-04-2020
30 ZOLL Medical Corporation II Mar-01-2018
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