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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
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
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
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 3
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 16056 16056
2017 14451 14451
2018 9849 9849
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 6744 6744

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12492 12492
Device Displays Incorrect Message 10389 10389
Output Problem 9397 9397
Device Operates Differently Than Expected 7171 7171
Circuit Failure 7064 7064
No Display/Image 6622 6622
Battery Problem 5637 5671
Failure to Recalibrate 4764 4764
Failure to Run on Battery 3911 3911
Defective Component 3814 3814
Device Inoperable 3697 3697
Failure to Calibrate 3681 3947
Failure to Charge 3595 3611
Electrical /Electronic Property Problem 3154 3154
Failure to Power Up 2803 2803
Display or Visual Feedback Problem 2332 2332
Device Operational Issue 2311 2311
Failure of Device to Self-Test 2198 2198
Protective Measures Problem 2054 2093
Gas/Air Leak 2019 2019
Improper Flow or Infusion 1815 1815
Incorrect Or Inadequate Test Results 1637 1637
Power Problem 1635 1677
Degraded 1619 1619
Leak/Splash 1423 1423
Insufficient Information 1400 1400
Appropriate Term/Code Not Available 1364 1364
Contamination 1355 1355
No Flow 1352 1352
Unexpected Shutdown 1292 1292
Infusion or Flow Problem 1242 1242
Failure to Deliver 1179 1179
Pressure Problem 1047 1047
Decrease in Pressure 1021 1021
Calibration Problem 1016 1016
Device Alarm System 958 958
Adverse Event Without Identified Device or Use Problem 941 941
Gas Output Problem 797 797
Insufficient Flow or Under Infusion 785 785
Erratic or Intermittent Display 752 752
Loss of Power 681 681
Therapeutic or Diagnostic Output Failure 668 668
Communication or Transmission Problem 630 630
Tidal Volume Fluctuations 611 611
Application Program Problem 605 605
Break 567 567
Incorrect, Inadequate or Imprecise Result or Readings 560 560
Charging Problem 547 547
Complete Loss of Power 517 517
Computer Software Problem 475 475
Noise, Audible 469 469
Inadequate User Interface 449 453
Inaccurate Delivery 440 440
Thermal Decomposition of Device 403 403
Connection Problem 399 399
Use of Device Problem 384 384
No Audible Alarm 331 331
Device Stops Intermittently 315 315
Inappropriate or Unexpected Reset 307 308
Increase in Pressure 306 306
Defective Device 300 300
Failure to Cycle 271 271
Application Interface Becomes Non-Functional Or Program Exits Abnormally 267 267
Device Sensing Problem 266 266
Reset Problem 264 264
Premature Discharge of Battery 252 252
Excess Flow or Over-Infusion 246 246
Loose or Intermittent Connection 245 245
Disconnection 245 245
Smoking 242 242
Volume Accuracy Problem 241 241
Defective Alarm 240 240
Temperature Problem 225 225
Computer Operating System Problem 214 214
Contamination /Decontamination Problem 212 212
Peeled/Delaminated 211 211
Aborted Charge 206 206
Alarm Not Visible 203 203
False Positive Result 194 194
Self-Activation or Keying 188 188
Obstruction of Flow 187 187
Medical Gas Supply Problem 187 187
Image Display Error/Artifact 179 179
No Pressure 174 174
Low Readings 173 173
Detachment of Device or Device Component 170 170
Suction Problem 165 165
Fracture 161 161
Failure to Conduct 159 159
Occlusion Within Device 145 145
Overheating of Device 144 144
Unexpected Therapeutic Results 135 135
Key or Button Unresponsive/not Working 134 134
Failure to Read Input Signal 132 132
Operating System Becomes Nonfunctional 131 131
Mechanical Jam 129 129
Device Emits Odor 120 120
Inaccurate Flow Rate 117 117
No Visual Prompts/Feedback 115 115
Ventilation Problem in Device Environment 113 113

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58776 58776
No Patient Involvement 28557 28557
No Consequences Or Impact To Patient 20634 21035
No Known Impact Or Consequence To Patient 5851 5852
No Information 2595 2595
Insufficient Information 1633 1633
Low Oxygen Saturation 1135 1136
No Code Available 1098 1098
Death 566 566
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 255 255
Unspecified Respiratory Problem 229 229
Dyspnea 229 229
Headache 169 169
Cardiac Arrest 166 166
Respiratory Failure 157 157
Respiratory Insufficiency 121 121
Hypoxia 89 89
Bradycardia 88 88
Respiratory Tract Infection 86 86
Respiratory Distress 83 83
Cough 83 83
Ventilator Dependent 79 79
Sore Throat 76 76
Dizziness 72 72
Cyanosis 60 60
Pneumothorax 59 59
Nausea 47 47
Hypoventilation 44 44
Respiratory Arrest 40 40
Patient Problem/Medical Problem 38 38
Low Blood Pressure/ Hypotension 37 37
Cardiopulmonary Arrest 36 36
Cancer 35 35
Pneumonia 32 32
Loss of consciousness 31 31
Injury 29 29
Discomfort 27 27
Unspecified Kidney or Urinary Problem 27 27
Skin Inflammation/ Irritation 26 26
Vomiting 26 26
Asthma 26 26
Apnea 26 26
Increased Respiratory Rate 24 24
Tachycardia 23 23
Respiratory Acidosis 21 21
Chronic Obstructive Pulmonary Disease (COPD) 19 19
Chest Pain 19 19
Hypersensitivity/Allergic reaction 19 19
Unspecified Infection 17 17
Inflammation 17 17
Burn(s) 15 15
Unspecified Heart Problem 15 15
Unspecified Eye / Vision Problem 15 15
Heart Failure/Congestive Heart Failure 12 12
Abnormal Blood Gases 12 12
Hyperventilation 12 12
Anxiety 11 11
Epistaxis 11 11
Unspecified Hepatic or Biliary Problem 11 11
Nodule 10 10
Pain 9 9
Fatigue 9 9
Stroke/CVA 9 9
Stacking Breaths 8 8
Dry Eye(s) 8 8
High Blood Pressure/ Hypertension 8 8
Renal Failure 8 8
Swelling/ Edema 8 8
Coma 7 7
Rash 7 7
Burning Sensation 7 7
Urinary Retention 6 6
Liver Damage/Dysfunction 6 6
Airway Obstruction 6 6
Aspiration/Inhalation 6 6
Decreased Respiratory Rate 6 6
Confusion/ Disorientation 6 6
Partial thickness (Second Degree) Burn 6 6
Bowel Perforation 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Sleep Dysfunction 5 5
Cognitive Changes 5 5
Electric Shock 5 5
Lethargy 5 5
Adult Respiratory Distress Syndrome 5 5
Pulmonary Emphysema 5 5
Encephalopathy 5 5
Necrosis 5 5
Hemoptysis 5 5
Hemorrhage/Bleeding 5 5
Fall 5 5
Fever 5 5
Perforation 5 5
Sinus Perforation 5 5
Brain Injury 5 5
Overinflation of Lung 5 5
Distress 4 4
Pleural Effusion 4 4
Myocardial Infarction 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Feb-24-2023
2 Breas Medical, Inc. II Apr-15-2022
3 COVIDIEN LLC I Dec-18-2018
4 Carefusion 211 Inc dba Carefusion I Jun-13-2016
5 Covidien LLC II Mar-27-2018
6 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
7 Covidien Llc II Nov-06-2020
8 Covidien, LP I Dec-09-2021
9 Datex-Ohmeda, Inc. II Aug-08-2018
10 Datex-Ohmeda, Inc. II Jun-01-2018
11 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
12 Draeger Medical, Inc. I Aug-18-2023
13 Draeger Medical, Inc. I Jul-08-2023
14 Draeger Medical, Inc. I Feb-24-2023
15 Draeger Medical, Inc. II Apr-04-2022
16 Draeger Medical, Inc. II Oct-14-2021
17 Draeger Medical, Inc. II May-28-2021
18 Draeger Medical, Inc. II May-29-2018
19 Draeger Medical, Inc. I Aug-04-2016
20 Draeger Medical, Inc. I Feb-25-2016
21 Draeger Medical, Inc. I Feb-03-2016
22 GE Healthcare, LLC I Jun-06-2022
23 GE Healthcare, LLC II Aug-24-2020
24 GE Healthcare, LLC II Dec-17-2019
25 GE Healthcare, LLC I Nov-30-2018
26 GE Medical Systems, LLC II Jan-21-2016
27 Getinge Group Logistics America, LLC II Oct-09-2020
28 Getinge Usa Sales Inc II Aug-24-2022
29 Getinge Usa Sales Inc I Aug-22-2022
30 Hamilton Medical AG II Apr-25-2023
31 Hamilton Medical AG II Nov-18-2022
32 Hamilton Medical AG I Aug-19-2022
33 Hamilton Medical AG I Jul-11-2019
34 Hamilton Medical AG II Aug-14-2018
35 Hamilton Medical AG II Apr-12-2018
36 Hamilton Medical, Inc. I Sep-20-2023
37 Hamilton Medical, Inc. I Jul-21-2023
38 Hamilton Medical, Inc. II Nov-28-2016
39 Hamilton Medical, Inc. II May-09-2016
40 Hill-Rom Manufacturing, Inc. II Nov-24-2020
41 Medtronic formerly Covidien I Apr-25-2022
42 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
43 Newport Medical Instruments Inc I Apr-10-2017
44 Percussionaire Corporation I Jan-17-2024
45 Percussionaire Corporation I Jan-17-2024
46 Percussionaire Corporation II Nov-07-2023
47 Philips Respironics II Mar-07-2016
48 Philips Respironics, Inc. I Apr-17-2024
49 Philips Respironics, Inc. II Jan-04-2024
50 Philips Respironics, Inc. II Jul-07-2023
51 Philips Respironics, Inc. I Jun-02-2023
52 Philips Respironics, Inc. I Apr-03-2023
53 Philips Respironics, Inc. I Jan-06-2023
54 Philips Respironics, Inc. I Mar-18-2022
55 Philips Respironics, Inc. I Jan-22-2022
56 Philips Respironics, Inc. II Aug-13-2021
57 Philips Respironics, Inc. I Jul-15-2021
58 Philips Respironics, Inc. I Feb-15-2020
59 ResMed Ltd. I Oct-23-2023
60 Resmed Corporation II Feb-03-2016
61 Spacelabs Healthcare, Ltd. I Aug-10-2018
62 Ventec Life Systems, Inc. I Feb-23-2024
63 Ventec Life Systems, Inc. II Jun-21-2021
64 Vyaire Medical II Jun-15-2023
65 Vyaire Medical I Feb-16-2022
66 Vyaire Medical II Mar-04-2020
67 ZOLL Medical Corporation II Mar-01-2018
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