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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
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 6
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 6
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
  1.  K163127  bellavista 1000
  2.  K183364  Bellavista
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 4386 4386

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 10076 10076
Device Operates Differently Than Expected 7171 7171
Mechanical Problem 5544 5544
No Display/Image 3978 3978
Battery Problem 3755 3789
Device Inoperable 3697 3697
Circuit Failure 3178 3178
Failure to Charge 2801 2817
Failure to Calibrate 2756 3022
Device Operational Issue 2311 2311
Failure to Recalibrate 2244 2244
Output Problem 1986 1986
Incorrect Or Inadequate Test Results 1637 1637
Failure to Power Up 1616 1616
Appropriate Term/Code Not Available 1258 1258
Protective Measures Problem 1229 1268
Failure of Device to Self-Test 1225 1225
Power Problem 978 1020
Device Alarm System 793 793
Display or Visual Feedback Problem 755 755
No Flow 721 721
Calibration Problem 712 712
Erratic or Intermittent Display 681 681
Loss of Power 662 662
Electrical /Electronic Property Problem 637 637
Leak/Splash 607 607
Adverse Event Without Identified Device or Use Problem 578 578
Pressure Problem 574 574
Insufficient Information 570 570
Failure to Deliver 543 543
Infusion or Flow Problem 502 502
Unexpected Shutdown 475 475
Incorrect, Inadequate or Imprecise Resultor Readings 466 466
Break 453 453
Tidal Volume Fluctuations 450 450
Improper Flow or Infusion 442 442
Therapeutic or Diagnostic Output Failure 437 437
Charging Problem 428 428
Thermal Decomposition of Device 394 394
Noise, Audible 380 380
Communication or Transmission Problem 369 369
Application Program Problem 352 352
Inaccurate Delivery 347 347
Gas Output Problem 334 334
Defective Component 327 327
Device Stops Intermittently 315 315
Contamination 308 308
Application Interface Becomes Non-Functional Or Program Exits Abnormally 267 267
Failure to Cycle 261 261
Inappropriate or Unexpected Reset 257 258
Defective Device 252 252
No Audible Alarm 251 251
Inadequate User Interface 246 250
Decrease in Pressure 244 244
Aborted Charge 204 204
Use of Device Problem 192 192
Volume Accuracy Problem 186 186
Self-Activation or Keying 180 180
Computer Operating System Problem 170 170
Reset Problem 163 163
Premature Discharge of Battery 149 149
Device Sensing Problem 149 149
No Pressure 147 147
Image Display Error/Artifact 145 145
Occlusion Within Device 145 145
Smoking 143 143
Disconnection 139 139
Temperature Problem 135 135
Gas Leak 132 132
Complete Loss of Power 130 130
Defective Alarm 124 124
Overheating of Device 117 117
Ventilation Problem in Device Environment 112 112
Computer Software Problem 110 110
Device Emits Odor 100 100
Operating System Becomes Nonfunctional 96 96
Increase in Pressure 96 96
Suction Problem 86 86
Detachment of Device or Device Component 85 85
Poor Quality Image 85 85
Contamination /Decontamination Problem 81 81
Low Readings 78 78
Connection Problem 71 71
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
Failure to Run on Battery 49 49
Nonstandard Device 49 49
Obstruction of Flow 48 48
Excess Flow or Over-Infusion 46 46
Improper Device Output 46 46
Data Problem 46 46
Sticking 45 45
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 Known Impact Or Consequence To Patient 5851 5852
No Clinical Signs, Symptoms or Conditions 5124 5124
No Information 2595 2595
No Code Available 1098 1098
Death 565 565
Low Oxygen Saturation 535 536
Insufficient Information 266 266
Respiratory Distress 83 83
Cardiac Arrest 73 73
Bradycardia 53 53
Hypoxia 43 43
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 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Loss of consciousness 16 16
Apnea 13 13
Tachycardia 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 6 6
Pain 5 5
Hyperventilation 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
Vomiting 4 4
Discomfort 4 4
High Oxygen Saturation 4 4
Burning Sensation 3 3
Ventricular Fibrillation 3 3
Necrosis 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
Tissue Damage 2 2
Brain Injury 2 2
Complaint, Ill-Defined 2 2
Therapeutic Response, Increased 2 2
Anxiety 2 2
Distress 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Ventilator Dependent 2 2
Pulmonary Edema 2 2
Premature Labor 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
Inadequate Osseointegration 1 1
Overinflation of Lung 1 1
Reaction 1 1
Arthralgia 1 1
Diabetic Ketoacidosis 1 1
Loss Of Pulse 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Weight Changes 1 1
Convulsion, Clonic 1 1
Pulmonary Dysfunction 1 1
Blurred Vision 1 1
Loss of Vision 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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