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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
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 5
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 5
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 3
RESMED
  SUBSTANTIALLY EQUIVALENT 2
RESMED CORP.
  SUBSTANTIALLY EQUIVALENT 2
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 11870 11870
2016 16049 16049
2017 14451 14451
2018 9848 9848
2019 9099 9099
2020 7979 7979

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 12948 12948
Device Operates Differently Than Expected 8902 8902
Device Inoperable 5057 5057
No Display/Image 4644 4644
Mechanical Problem 4088 4088
Battery Problem 3519 3519
Failure to Charge 3307 3307
Failure to Calibrate 2754 2754
Circuit Failure 2502 2502
Device Operational Issue 2339 2339
Incorrect Or Inadequate Test Results 2020 2020
Failure to Power Up 1840 1840
Failure to Recalibrate 1744 1744
Appropriate Term/Code Not Available 1638 1638
Device Alarm System 1020 1020
Failure of Device to Self-Test 1020 1020
Output Problem 1014 1014
Power Problem 963 963
Loss of Power 912 912
Erratic or Intermittent Display 861 861
Protective Measures Problem 839 839
Screen 776 776
Calibration Problem 721 721
Battery 701 701
Adverse Event Without Identified Device or Use Problem 668 668
No Flow 637 637
Break 627 627
Leak/Splash 593 593
Display or Visual Feedback Problem 586 586
Inaccurate Delivery 569 569
Failure to Deliver 556 556
Electrical /Electronic Property Problem 545 545
Tidal Volume Fluctuations 526 526
Pressure Problem 517 517
Charging Problem 495 495
Failure to Cycle 462 462
Noise, Audible 461 461
Thermal Decomposition of Device 436 436
Incorrect, Inadequate or Imprecise Resultor Readings 431 431
Insufficient Information 417 417
Communication or Transmission Problem 405 405
Display 405 405
Device Stops Intermittently 374 374
Therapeutic or Diagnostic Output Failure 367 367
Improper Flow or Infusion 363 363
Application Interface Becomes Non-Functional Or Program Exits Abnormally 353 353
Unexpected Shutdown 352 352
Infusion or Flow Problem 336 336
Application Program Problem 303 303
Self-Activation or Keying 300 300
No Audible Alarm 292 292
Inappropriate or Unexpected Reset 275 275
Defective Component 269 269
Contamination 265 265
Volume Accuracy Problem 258 258
Image Display Error/Artifact 252 252
Defective Device 249 249
Gas Output Problem 239 239
Device Maintenance Issue 230 230
Occlusion Within Device 225 225
Aborted Charge 208 208
Computer Operating System Problem 201 201
Valve(s) 199 199
Alarm, Audible 192 192
Sensor 191 191
Keypad 189 189
Use of Device Problem 184 184
Decrease in Pressure 184 184
Device Sensing Problem 172 172
Disconnection 169 169
Inadequate User Interface 167 167
Premature Discharge of Battery 165 165
Smoking 159 159
Ventilation Problem in Device Environment 157 157
No Pressure 150 150
Poor Quality Image 147 147
Increase in Pressure 145 145
Reset Problem 140 140
Temperature Problem 133 133
Device Emits Odor 130 130
Defective Alarm 127 127
Gas Leak 116 116
Overheating of Device 113 113
O2 Sensor 106 106
Switch, Push Button 95 95
Crack 91 91
Power Supply 90 90
Operating System Becomes Nonfunctional 89 89
Computer Software Problem 89 89
Complete Loss of Power 87 87
Connection Problem 87 87
Suction Problem 86 86
Failure To Run On AC/DC 78 78
Compressor 77 77
Detachment Of Device Component 77 77
Sticking 77 77
Improper Device Output 74 74
Detachment of Device or Device Component 73 73
Low Readings 69 69
Connector 69 69

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 33365 33365
No Consequences Or Impact To Patient 21949 21949
No Known Impact Or Consequence To Patient 8966 8966
No Information 2741 2741
No Code Available 1130 1130
Death 634 634
Low Oxygen Saturation 530 531
No Clinical Signs, Symptoms or Conditions 358 358
Respiratory Distress 103 103
Cardiac Arrest 67 67
Bradycardia 53 53
Patient Problem/Medical Problem 52 52
Hypoxia 44 44
Cyanosis 38 38
Cardiopulmonary Arrest 36 36
Dyspnea 35 35
Hypoventilation 34 34
Injury 34 34
Pneumothorax 27 27
Low Blood Pressure/ Hypotension 25 25
Loss of consciousness 19 19
Respiratory Failure 18 18
Apnea 18 18
Insufficient Information 17 17
Tachycardia 13 13
Urinary Retention 11 11
Respiratory Acidosis 11 11
Burn(s) 10 10
Stacking Breaths 9 9
Pneumonia 9 9
Complaint, Ill-Defined 8 8
Increased Respiratory Rate 8 8
Discomfort 7 7
Pain 6 6
Unspecified Infection 6 6
High Blood Pressure/ Hypertension 6 6
Decreased Respiratory Rate 6 6
Extubate 6 6
Hyperventilation 5 5
Brain Injury 5 5
Foreign Body In Patient 5 5
Diminished Pulse Pressure 5 5
Inadequate Osseointegration 4 4
High Oxygen Saturation 4 4
Device Embedded In Tissue or Plaque 4 4
Vomiting 4 4
Abnormal Blood Gases 4 4
Cognitive Changes 4 4
Lethargy 4 4
Cancer 3 3
Coma 3 3
Ventricular Tachycardia 3 3
Respiratory Alkalosis 3 3
Sweating 3 3
Neurological Deficit/Dysfunction 3 3
Perforation 3 3
Aspiration/Inhalation 3 3
Encephalopathy 3 3
Eye Injury 3 3
Burning Sensation 3 3
Distress 3 3
Therapeutic Response, Increased 2 2
Anxiety 2 2
Ventilator Dependent 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Premature Labor 2 2
Weakness 2 2
Tissue Damage 2 2
Ventricular Fibrillation 2 2
Respiratory Distress Syndrome of Newborns 2 2
Chest Pain 2 2
Bruise/Contusion 2 2
Pleural Effusion 2 2
Pulmonary Dysfunction 2 2
Pulmonary Edema 2 2
Hemorrhage/Bleeding 2 2
Test Result 2 2
Chemical Exposure 2 2
Fatigue 2 2
Crushing Injury 2 2
Septic Shock 2 2
Skin Discoloration 2 2
Swelling 2 2
Rupture 2 2
Pulmonary Emphysema 2 2
Pallor 2 2
Pressure Sores 2 2
Sedation 2 2
Bowel Perforation 2 2
Partial thickness (Second Degree) Burn 2 2
Vascular Dissection 2 2
Multiple Organ Failure 2 2
Abdominal Distention 1 1
Osteopenia/ Osteoporosis 1 1
Superficial (First Degree) Burn 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Collapse 1 1
Malaise 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 Carefusion 211 Inc dba Carefusion I May-26-2015
4 Covidien LLC II Mar-27-2018
5 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
6 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
7 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
8 Datex-Ohmeda, Inc. II Aug-08-2018
9 Datex-Ohmeda, Inc. II Jun-01-2018
10 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
11 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
12 Draeger Medical, Inc. II May-29-2018
13 Draeger Medical, Inc. I Aug-04-2016
14 Draeger Medical, Inc. I Feb-25-2016
15 Draeger Medical, Inc. I Feb-03-2016
16 Draeger Medical, Inc. I Dec-23-2015
17 Draeger Medical, Inc. I Aug-14-2015
18 Event Medical LTD I Nov-19-2015
19 GE Healthcare II Mar-24-2015
20 GE Healthcare, LLC II Aug-24-2020
21 GE Healthcare, LLC II Dec-17-2019
22 GE Healthcare, LLC I Nov-30-2018
23 GE Medical Systems, LLC II Jan-21-2016
24 Getinge Group Logistics America, LLC II Oct-09-2020
25 Hamilton Medical AG I Jul-11-2019
26 Hamilton Medical AG II Aug-14-2018
27 Hamilton Medical AG II Apr-12-2018
28 Hamilton Medical, Inc. II Nov-28-2016
29 Hamilton Medical, Inc. II May-09-2016
30 Hamilton Medical, Inc. I Nov-04-2015
31 Hamilton Medical, Inc. II Jul-10-2015
32 Newport Medical Instruments Inc I Apr-10-2017
33 Philips Respironics II Mar-07-2016
34 Philips Respironics, Inc. I Feb-15-2020
35 ResMed Ltd. II Jun-10-2015
36 Resmed Corporation II Feb-03-2016
37 Spacelabs Healthcare, Ltd. I Aug-10-2018
38 Vyaire Medical II Mar-04-2020
39 ZOLL Medical Corporation II Mar-01-2018
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