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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
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 7
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 3
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 2
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2015 11874 11874
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
Device Displays Incorrect Message 13506 13506
Mechanical Problem 12528 12528
Output Problem 9405 9405
Device Operates Differently Than Expected 8906 8906
No Display/Image 7525 7525
Circuit Failure 7077 7077
Battery Problem 6182 6216
Device Inoperable 5058 5058
Failure to Recalibrate 4767 4767
Failure to Charge 4444 4460
Failure to Run on Battery 3918 3918
Defective Component 3824 3824
Failure to Calibrate 3788 4054
Electrical /Electronic Property Problem 3206 3206
Failure to Power Up 3205 3205
Display or Visual Feedback Problem 2451 2451
Device Operational Issue 2339 2339
Failure of Device to Self-Test 2293 2293
Protective Measures Problem 2059 2098
Gas/Air Leak 2025 2025
Incorrect Or Inadequate Test Results 2020 2020
Improper Flow or Infusion 1842 1842
Appropriate Term/Code Not Available 1767 1767
Power Problem 1709 1751
Degraded 1640 1640
Leak/Splash 1519 1519
Insufficient Information 1431 1431
Contamination 1382 1382
No Flow 1378 1378
Unexpected Shutdown 1293 1293
Failure to Deliver 1279 1279
Infusion or Flow Problem 1277 1277
Device Alarm System 1208 1208
Pressure Problem 1131 1131
Calibration Problem 1109 1109
Adverse Event Without Identified Device or Use Problem 1069 1069
Decrease in Pressure 1040 1040
Erratic or Intermittent Display 939 939
Loss of Power 935 935
Gas Output Problem 810 810
Insufficient Flow or Under Infusion 791 791
Break 761 761
Tidal Volume Fluctuations 702 702
Communication or Transmission Problem 699 699
Therapeutic or Diagnostic Output Failure 682 682
Inaccurate Delivery 676 676
Charging Problem 628 628
Application Program Problem 611 611
Noise, Audible 573 573
Incorrect, Inadequate or Imprecise Result or Readings 562 562
Complete Loss of Power 517 517
Failure to Cycle 483 483
Computer Software Problem 477 477
Inadequate User Interface 451 455
Thermal Decomposition of Device 448 448
Connection Problem 420 420
Use of Device Problem 411 411
No Audible Alarm 378 378
Device Stops Intermittently 374 374
Increase in Pressure 367 367
Application Interface Becomes Non-Functional Or Program Exits Abnormally 353 353
Inappropriate or Unexpected Reset 343 344
Volume Accuracy Problem 317 317
Defective Device 315 315
Self-Activation or Keying 310 310
Device Sensing Problem 305 305
Image Display Error/Artifact 287 287
Premature Discharge of Battery 285 285
Disconnection 284 284
Reset Problem 281 281
Smoking 271 271
Excess Flow or Over-Infusion 257 257
Defective Alarm 256 256
Loose or Intermittent Connection 255 255
Computer Operating System Problem 249 249
Temperature Problem 238 238
Device Maintenance Issue 230 230
Occlusion Within Device 225 225
Contamination /Decontamination Problem 212 212
Aborted Charge 211 211
Peeled/Delaminated 211 211
Alarm Not Visible 205 205
False Positive Result 194 194
Obstruction of Flow 193 193
Medical Gas Supply Problem 193 193
No Pressure 182 182
Low Readings 174 174
Detachment of Device or Device Component 171 171
Suction Problem 165 165
Fracture 162 162
Ventilation Problem in Device Environment 160 160
Failure to Conduct 159 159
Poor Quality Image 156 156
Overheating of Device 153 153
Device Emits Odor 151 151
Operating System Becomes Nonfunctional 144 144
Mechanical Jam 136 136
Unexpected Therapeutic Results 135 135
Key or Button Unresponsive/not Working 134 134
Failure to Read Input Signal 132 132

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58797 58797
No Patient Involvement 34217 34217
No Consequences Or Impact To Patient 23307 23708
No Known Impact Or Consequence To Patient 8973 8974
No Information 2842 2842
Insufficient Information 1635 1635
Low Oxygen Saturation 1221 1222
No Code Available 1130 1130
Death 665 665
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 255 255
Dyspnea 247 247
Unspecified Respiratory Problem 229 229
Cardiac Arrest 181 181
Headache 169 169
Respiratory Failure 160 160
Respiratory Insufficiency 121 121
Respiratory Distress 103 103
Hypoxia 96 96
Bradycardia 96 96
Respiratory Tract Infection 86 86
Cough 83 83
Ventilator Dependent 79 79
Sore Throat 76 76
Dizziness 72 72
Cyanosis 65 65
Pneumothorax 63 63
Hypoventilation 54 54
Patient Problem/Medical Problem 52 52
Nausea 47 47
Low Blood Pressure/ Hypotension 42 42
Respiratory Arrest 40 40
Loss of consciousness 38 38
Pneumonia 38 38
Injury 37 37
Cardiopulmonary Arrest 37 37
Cancer 37 37
Apnea 33 33
Discomfort 31 31
Increased Respiratory Rate 28 28
Unspecified Kidney or Urinary Problem 27 27
Skin Inflammation/ Irritation 26 26
Asthma 26 26
Vomiting 26 26
Tachycardia 24 24
Respiratory Acidosis 23 23
Chest Pain 20 20
Hypersensitivity/Allergic reaction 19 19
Chronic Obstructive Pulmonary Disease (COPD) 19 19
Unspecified Infection 17 17
Inflammation 17 17
Burn(s) 15 15
Unspecified Eye / Vision Problem 15 15
Unspecified Heart Problem 15 15
Abnormal Blood Gases 14 14
Hyperventilation 12 12
Heart Failure/Congestive Heart Failure 12 12
Epistaxis 11 11
Unspecified Hepatic or Biliary Problem 11 11
Anxiety 11 11
Urinary Retention 11 11
Pain 10 10
High Blood Pressure/ Hypertension 10 10
Fatigue 10 10
Nodule 10 10
Stacking Breaths 9 9
Stroke/CVA 9 9
Dry Eye(s) 8 8
Renal Failure 8 8
Brain Injury 8 8
Swelling/ Edema 8 8
Decreased Respiratory Rate 8 8
Complaint, Ill-Defined 8 8
Coma 8 8
Bowel Perforation 8 8
Burning Sensation 7 7
Rash 7 7
Liver Damage/Dysfunction 7 7
Aspiration/Inhalation 7 7
Airway Obstruction 6 6
Hemorrhage/Bleeding 6 6
Encephalopathy 6 6
Fever 6 6
Foreign Body In Patient 6 6
Partial thickness (Second Degree) Burn 6 6
Extubate 6 6
Cognitive Changes 6 6
Confusion/ Disorientation 6 6
Sleep Dysfunction 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Electric Shock 5 5
Lethargy 5 5
Diminished Pulse Pressure 5 5
Fall 5 5
Hemoptysis 5 5
Pulmonary Emphysema 5 5
Adult Respiratory Distress Syndrome 5 5
Perforation 5 5
Pleural Effusion 5 5
Necrosis 5 5

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 Carefusion 211 Inc dba Carefusion I May-26-2015
6 Covidien LLC II Mar-27-2018
7 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
8 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
9 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
10 Covidien Llc II Nov-06-2020
11 Covidien, LP I Dec-09-2021
12 Datex-Ohmeda, Inc. II Aug-08-2018
13 Datex-Ohmeda, Inc. II Jun-01-2018
14 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
15 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
16 Draeger Medical, Inc. I Aug-18-2023
17 Draeger Medical, Inc. I Jul-08-2023
18 Draeger Medical, Inc. I Feb-24-2023
19 Draeger Medical, Inc. II Apr-04-2022
20 Draeger Medical, Inc. II Oct-14-2021
21 Draeger Medical, Inc. II May-28-2021
22 Draeger Medical, Inc. II May-29-2018
23 Draeger Medical, Inc. I Aug-04-2016
24 Draeger Medical, Inc. I Feb-25-2016
25 Draeger Medical, Inc. I Feb-03-2016
26 Draeger Medical, Inc. I Dec-23-2015
27 Draeger Medical, Inc. I Aug-14-2015
28 Event Medical LTD I Nov-19-2015
29 GE Healthcare II Mar-24-2015
30 GE Healthcare, LLC I Jun-06-2022
31 GE Healthcare, LLC II Aug-24-2020
32 GE Healthcare, LLC II Dec-17-2019
33 GE Healthcare, LLC I Nov-30-2018
34 GE Medical Systems, LLC II Jan-21-2016
35 Getinge Group Logistics America, LLC II Oct-09-2020
36 Getinge Usa Sales Inc II Aug-24-2022
37 Getinge Usa Sales Inc I Aug-22-2022
38 Hamilton Medical AG II Apr-25-2023
39 Hamilton Medical AG II Nov-18-2022
40 Hamilton Medical AG I Aug-19-2022
41 Hamilton Medical AG I Jul-11-2019
42 Hamilton Medical AG II Aug-14-2018
43 Hamilton Medical AG II Apr-12-2018
44 Hamilton Medical, Inc. I Sep-20-2023
45 Hamilton Medical, Inc. I Jul-21-2023
46 Hamilton Medical, Inc. II Nov-28-2016
47 Hamilton Medical, Inc. II May-09-2016
48 Hamilton Medical, Inc. I Nov-04-2015
49 Hamilton Medical, Inc. II Jul-10-2015
50 Hill-Rom Manufacturing, Inc. II Nov-24-2020
51 Medtronic formerly Covidien I Apr-25-2022
52 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
53 Newport Medical Instruments Inc I Apr-10-2017
54 Percussionaire Corporation I Jan-17-2024
55 Percussionaire Corporation I Jan-17-2024
56 Percussionaire Corporation II Nov-07-2023
57 Philips Respironics II Mar-07-2016
58 Philips Respironics, Inc. I Apr-17-2024
59 Philips Respironics, Inc. II Jan-04-2024
60 Philips Respironics, Inc. II Jul-07-2023
61 Philips Respironics, Inc. I Jun-02-2023
62 Philips Respironics, Inc. I Apr-03-2023
63 Philips Respironics, Inc. I Jan-06-2023
64 Philips Respironics, Inc. I Mar-18-2022
65 Philips Respironics, Inc. I Jan-22-2022
66 Philips Respironics, Inc. II Aug-13-2021
67 Philips Respironics, Inc. I Jul-15-2021
68 Philips Respironics, Inc. I Feb-15-2020
69 ResMed Ltd. I Oct-23-2023
70 ResMed Ltd. II Jun-10-2015
71 Resmed Corporation II Feb-03-2016
72 Spacelabs Healthcare, Ltd. I Aug-10-2018
73 Ventec Life Systems, Inc. I Feb-23-2024
74 Ventec Life Systems, Inc. II Jun-21-2021
75 Vyaire Medical II Jun-15-2023
76 Vyaire Medical I Feb-16-2022
77 Vyaire Medical II Mar-04-2020
78 ZOLL Medical Corporation II Mar-01-2018
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