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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
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
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
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 2
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 9849 9849
2019 9100 9502
2020 11097 11097
2021 13328 13328
2022 16048 16048
2023 7016 7016

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 10386 10386
Output Problem 7003 7003
Circuit Failure 5303 5303
Failure to Recalibrate 3900 3900
Battery Problem 3629 3663
No Display/Image 3183 3183
Failure to Run on Battery 2945 2945
Device Displays Incorrect Message 2450 2450
Failure to Charge 2170 2186
Protective Measures Problem 2065 2104
Failure to Calibrate 2005 2271
Failure of Device to Self-Test 1714 1714
Display or Visual Feedback Problem 1700 1700
Electrical /Electronic Property Problem 1568 1568
Failure to Power Up 1551 1551
Degraded 1426 1426
Defective Component 1246 1246
No Flow 1036 1036
Device Operates Differently Than Expected 1011 1011
Unexpected Shutdown 982 982
Improper Flow or Infusion 956 956
Contamination 953 953
Infusion or Flow Problem 927 927
Power Problem 827 869
Failure to Deliver 814 814
Leak/Splash 711 711
Calibration Problem 710 710
Insufficient Information 700 700
Pressure Problem 644 644
Device Operational Issue 614 614
Therapeutic or Diagnostic Output Failure 574 574
Gas Output Problem 552 552
Application Program Problem 547 547
Incorrect, Inadequate or Imprecise Result or Readings 527 527
Inadequate User Interface 471 475
Device Inoperable 465 465
Decrease in Pressure 459 459
Device Alarm System 426 426
Adverse Event Without Identified Device or Use Problem 359 359
Gas/Air Leak 317 317
Use of Device Problem 305 305
Tidal Volume Fluctuations 286 286
Appropriate Term/Code Not Available 283 283
Communication or Transmission Problem 275 275
Defective Device 271 271
Complete Loss of Power 266 266
Computer Software Problem 251 251
Incorrect Or Inadequate Test Results 242 242
Charging Problem 208 208
Connection Problem 207 207
Break 202 202
Premature Discharge of Battery 195 195
Reset Problem 194 194
Peeled/Delaminated 192 192
Inaccurate Delivery 189 189
Loss of Power 188 188
Noise, Audible 183 183
Temperature Problem 182 182
Contamination /Decontamination Problem 180 180
Defective Alarm 176 176
Increase in Pressure 174 174
Aborted Charge 170 170
Smoking 149 149
No Audible Alarm 146 146
Inappropriate or Unexpected Reset 142 143
No Pressure 131 131
Detachment of Device or Device Component 121 121
Failure to Cycle 119 119
Erratic or Intermittent Display 116 116
Fracture 113 113
Volume Accuracy Problem 107 107
Obstruction of Flow 88 88
Disconnection 86 86
Unexpected Therapeutic Results 77 77
Operating System Becomes Nonfunctional 75 75
Device Sensing Problem 71 71
Overheating of Device 71 71
Low Readings 63 63
Tactile Prompts/Feedback 61 61
Unintended Collision 59 59
Thermal Decomposition of Device 57 57
Computer Operating System Problem 57 57
Key or Button Unresponsive/not Working 52 52
Insufficient Flow or Under Infusion 51 51
No Apparent Adverse Event 50 50
Activation Problem 50 50
Device Stops Intermittently 49 49
Intermittent Loss of Power 47 47
Data Problem 46 46
High Readings 46 46
Failure to Read Input Signal 45 45
Loose or Intermittent Connection 44 44
Device Emits Odor 43 43
Inaccurate Flow Rate 43 43
Device Handling Problem 43 43
Ventilation Problem in Device Environment 43 43
Image Display Error/Artifact 42 42
False Alarm 42 42
Application Program Freezes, Becomes Nonfunctional 42 42
Accessory Incompatible 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34937 34937
No Patient Involvement 12810 12810
No Consequences Or Impact To Patient 12241 12642
No Known Impact Or Consequence To Patient 1783 1784
Insufficient Information 1419 1419
No Information 1078 1078
Low Oxygen Saturation 747 747
No Code Available 446 446
Death 271 271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 202 202
Dyspnea 170 170
Headache 111 111
Cardiac Arrest 102 102
Cough 68 68
Respiratory Tract Infection 62 62
Sore Throat 61 61
Ventilator Dependent 60 60
Unspecified Respiratory Problem 58 58
Bradycardia 56 56
Hypoxia 55 55
Pneumothorax 38 38
Respiratory Distress 38 38
Respiratory Failure 33 33
Respiratory Arrest 32 32
Nausea 31 31
Dizziness 30 30
Low Blood Pressure/ Hypotension 27 27
Cyanosis 27 27
Hypoventilation 26 26
Patient Problem/Medical Problem 26 26
Pneumonia 24 24
Cardiopulmonary Arrest 21 21
Increased Respiratory Rate 20 20
Loss of consciousness 16 16
Tachycardia 15 15
Chest Pain 15 15
Cancer 15 15
Respiratory Insufficiency 15 15
Unspecified Eye / Vision Problem 14 14
Discomfort 14 14
Injury 14 14
Chronic Obstructive Pulmonary Disease (COPD) 13 13
Respiratory Acidosis 13 13
Apnea 13 13
Unspecified Infection 13 13
Vomiting 10 10
Dry Eye(s) 8 8
Epistaxis 8 8
Heart Failure/Congestive Heart Failure 8 8
Unspecified Kidney or Urinary Problem 8 8
Skin Inflammation/ Irritation 8 8
Fatigue 7 7
Abnormal Blood Gases 7 7
Hyperventilation 7 7
Rash 7 7
Pain 7 7
Anxiety 7 7
Urinary Retention 6 6
Renal Failure 6 6
High Blood Pressure/ Hypertension 6 6
Inflammation 6 6
Aspiration/Inhalation 6 6
Burn(s) 6 6
Convulsion/Seizure 6 6
Bowel Perforation 6 6
Unspecified Heart Problem 5 5
Swelling/ Edema 5 5
Hypersensitivity/Allergic reaction 5 5
Hemoptysis 4 4
Perforation 4 4
Necrosis 4 4
Bacterial Infection 4 4
Asthma 4 4
Fever 4 4
Brain Injury 4 4
Decreased Respiratory Rate 4 4
Coma 4 4
Electric Shock 4 4
Abdominal Distention 4 4
Dry Mouth 4 4
Wheezing 4 4
Speech Disorder 4 4
Taste Disorder 3 3
Thrombosis/Thrombus 3 3
Unspecified Gastrointestinal Problem 3 3
Nodule 3 3
Respiratory Alkalosis 3 3
Choking 3 3
Sinus Perforation 3 3
Burning Sensation 3 3
Therapeutic Effects, Unexpected 3 3
Emotional Changes 3 3
Pulmonary Emphysema 3 3
Atrial Fibrillation 3 3
Arrhythmia 3 3
Adult Respiratory Distress Syndrome 3 3
Airway Obstruction 3 3
Pulmonary Embolism 2 2
Bronchitis 2 2
Stroke/CVA 2 2

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 Covidien LLC II Mar-27-2018
5 Covidien Llc II Nov-06-2020
6 Covidien, LP I Dec-09-2021
7 Datex-Ohmeda, Inc. II Aug-08-2018
8 Datex-Ohmeda, Inc. II Jun-01-2018
9 Draeger Medical, Inc. I Feb-24-2023
10 Draeger Medical, Inc. II Apr-04-2022
11 Draeger Medical, Inc. II Oct-14-2021
12 Draeger Medical, Inc. II May-28-2021
13 Draeger Medical, Inc. II May-29-2018
14 GE Healthcare, LLC I Jun-06-2022
15 GE Healthcare, LLC II Aug-24-2020
16 GE Healthcare, LLC II Dec-17-2019
17 GE Healthcare, LLC I Nov-30-2018
18 Getinge Group Logistics America, LLC II Oct-09-2020
19 Getinge Usa Sales Inc II Aug-24-2022
20 Getinge Usa Sales Inc I Aug-22-2022
21 Hamilton Medical AG II Apr-25-2023
22 Hamilton Medical AG II Nov-18-2022
23 Hamilton Medical AG I Aug-19-2022
24 Hamilton Medical AG I Jul-11-2019
25 Hamilton Medical AG II Aug-14-2018
26 Hamilton Medical AG II Apr-12-2018
27 Hill-Rom Manufacturing, Inc. II Nov-24-2020
28 Medtronic formerly Covidien I Apr-25-2022
29 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
30 Philips Respironics, Inc. I Jun-02-2023
31 Philips Respironics, Inc. I Apr-03-2023
32 Philips Respironics, Inc. I Jan-06-2023
33 Philips Respironics, Inc. I Mar-18-2022
34 Philips Respironics, Inc. I Jan-22-2022
35 Philips Respironics, Inc. II Aug-13-2021
36 Philips Respironics, Inc. I Jul-15-2021
37 Philips Respironics, Inc. I Feb-15-2020
38 Spacelabs Healthcare, Ltd. I Aug-10-2018
39 Ventec Life Systems, Inc. II Jun-21-2021
40 Vyaire Medical I Feb-16-2022
41 Vyaire Medical II Mar-04-2020
42 ZOLL Medical Corporation II Mar-01-2018
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