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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 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  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 5
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 2
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
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
2017 14451 14451
2018 9848 9848
2019 9099 9501
2020 11096 11096
2021 13326 13326
2022 4285 4285

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 7939 7939
Device Displays Incorrect Message 6047 6047
Output Problem 4681 4681
Circuit Failure 4068 4068
Device Operates Differently Than Expected 3745 3745
Battery Problem 3692 3726
No Display/Image 3130 3130
Failure to Recalibrate 2979 2979
Failure to Calibrate 2719 2985
Failure to Charge 1996 2012
Device Inoperable 1968 1968
Device Operational Issue 1804 1804
Protective Measures Problem 1688 1727
Failure to Power Up 1600 1600
Failure of Device to Self-Test 1472 1472
Display or Visual Feedback Problem 1202 1202
Power Problem 1043 1085
Incorrect Or Inadequate Test Results 906 906
Degraded 886 886
Electrical /Electronic Property Problem 879 879
No Flow 843 843
Infusion or Flow Problem 771 771
Unexpected Shutdown 731 731
Leak/Splash 697 697
Calibration Problem 685 685
Failure to Deliver 659 659
Insufficient Information 656 656
Pressure Problem 629 629
Device Alarm System 608 608
Improper Flow or Infusion 553 553
Therapeutic or Diagnostic Output Failure 525 525
Incorrect, Inadequate or Imprecise Resultor Readings 495 495
Appropriate Term/Code Not Available 456 456
Gas Output Problem 433 433
Contamination 425 425
Erratic or Intermittent Display 408 408
Application Program Problem 407 407
Adverse Event Without Identified Device or Use Problem 405 405
Loss of Power 397 397
Defective Component 363 363
Tidal Volume Fluctuations 358 358
Charging Problem 357 357
Inadequate User Interface 355 359
Decrease in Pressure 338 338
Noise, Audible 325 325
Communication or Transmission Problem 302 302
Inaccurate Delivery 292 292
Break 278 278
Defective Device 263 263
Use of Device Problem 258 258
Device Stops Intermittently 211 211
Inappropriate or Unexpected Reset 201 202
Aborted Charge 195 195
No Audible Alarm 188 188
Complete Loss of Power 182 182
Reset Problem 181 181
Computer Software Problem 181 181
Gas Leak 176 176
Temperature Problem 170 170
Defective Alarm 159 159
Premature Discharge of Battery 157 157
Volume Accuracy Problem 157 157
Device Sensing Problem 150 150
Smoking 146 146
Failure to Cycle 140 140
No Pressure 138 138
Connection Problem 127 127
Contamination /Decontamination Problem 126 126
Increase in Pressure 123 123
Disconnection 111 111
Occlusion Within Device 107 107
Detachment of Device or Device Component 102 102
Thermal Decomposition of Device 95 95
Overheating of Device 92 92
Computer Operating System Problem 92 92
Failure to Run on Battery 85 85
Low Readings 83 83
Ventilation Problem in Device Environment 81 81
Device Emits Odor 68 68
Failure to Read Input Signal 64 64
Self-Activation or Keying 63 63
High Readings 61 61
Obstruction of Flow 60 60
Suction Problem 57 57
Operating System Becomes Nonfunctional 52 52
Unexpected Therapeutic Results 49 49
Fire 48 48
Image Display Error/Artifact 47 47
Unintended Collision 45 45
Loose or Intermittent Connection 44 44
Data Problem 44 44
Poor Quality Image 43 43
Application Interface Becomes Non-Functional Or Program Exits Abnormally 43 43
Excess Flow or Over-Infusion 42 42
Human-Device Interface Problem 42 42
Tactile Prompts/Feedback 42 42
Activation Problem 42 42
Failure to Sense 41 41
Fracture 41 41
False Alarm 40 40

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 20332 20332
No Clinical Signs, Symptoms or Conditions 17459 17459
No Consequences Or Impact To Patient 16619 17020
No Known Impact Or Consequence To Patient 3033 3034
No Information 1889 1889
No Code Available 1081 1081
Insufficient Information 862 862
Low Oxygen Saturation 631 632
Death 396 396
Cardiac Arrest 91 91
Respiratory Distress 61 61
Bradycardia 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 55
Dyspnea 50 50
Hypoxia 48 48
Cyanosis 38 38
Pneumothorax 36 36
Cardiopulmonary Arrest 27 27
Patient Problem/Medical Problem 27 27
Hypoventilation 26 26
Low Blood Pressure/ Hypotension 23 23
Respiratory Failure 23 23
Injury 22 22
Respiratory Arrest 22 22
Increased Respiratory Rate 15 15
Pneumonia 14 14
Apnea 13 13
Tachycardia 12 12
Cough 12 12
Discomfort 11 11
Respiratory Acidosis 11 11
Loss of consciousness 11 11
Burn(s) 11 11
Unspecified Infection 10 10
Headache 9 9
Unspecified Respiratory Problem 9 9
Cancer 8 8
Respiratory Tract Infection 8 8
Sore Throat 8 8
Chronic Obstructive Pulmonary Disease (COPD) 8 8
Anxiety 7 7
Urinary Retention 6 6
Abnormal Blood Gases 6 6
Nausea 6 6
Heart Failure/Congestive Heart Failure 6 6
Respiratory Insufficiency 6 6
Unspecified Kidney or Urinary Problem 5 5
High Blood Pressure/ Hypertension 5 5
Hyperventilation 5 5
Aspiration/Inhalation 5 5
Vomiting 5 5
Coma 5 5
Bowel Perforation 4 4
Pulmonary Emphysema 4 4
Dry Eye(s) 4 4
Perforation 4 4
Renal Failure 3 3
Pain 3 3
Necrosis 3 3
Inflammation 3 3
Asthma 3 3
Stacking Breaths 3 3
Adult Respiratory Distress Syndrome 3 3
Airway Obstruction 3 3
Foreign Body In Patient 3 3
Decreased Respiratory Rate 3 3
Therapeutic Effects, Unexpected 3 3
Skin Inflammation/ Irritation 3 3
Convulsion/Seizure 3 3
Thrombosis/Thrombus 3 3
Multiple Organ Failure 2 2
Vascular Dissection 2 2
Unspecified Heart Problem 2 2
Unspecified Eye / Vision Problem 2 2
Nodule 2 2
Drug Resistant Bacterial Infection 2 2
Septic Shock 2 2
Burning Sensation 2 2
Ventricular Fibrillation 2 2
Ventricular Tachycardia 2 2
Distress 2 2
Therapeutic Response, Increased 2 2
Pressure Sores 2 2
Brain Injury 2 2
Extubate 2 2
Sedation 2 2
Ventilator Dependent 2 2
Respiratory Alkalosis 2 2
Sweating 2 2
Premature Labor 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Lethargy 2 2
Arrhythmia 2 2
Bacterial Infection 2 2
Bronchitis 2 2
Bruise/Contusion 2 2
Crushing Injury 2 2
Hematoma 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Breas Medical, Inc. II Apr-15-2022
2 COVIDIEN LLC I Dec-18-2018
3 Covidien LLC II Mar-27-2018
4 Covidien Llc II Nov-06-2020
5 Covidien, LP I Apr-25-2022
6 Covidien, LP I Dec-09-2021
7 Datex-Ohmeda, Inc. II Aug-08-2018
8 Datex-Ohmeda, Inc. II Jun-01-2018
9 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
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 II Aug-24-2020
15 GE Healthcare, LLC II Dec-17-2019
16 GE Healthcare, LLC I Nov-30-2018
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 Hill-Rom Manufacturing, Inc. II Nov-24-2020
22 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
23 Newport Medical Instruments Inc I Apr-10-2017
24 Philips Respironics, Inc. I Mar-18-2022
25 Philips Respironics, Inc. I Jan-22-2022
26 Philips Respironics, Inc. II Aug-13-2021
27 Philips Respironics, Inc. I Jul-15-2021
28 Philips Respironics, Inc. I Feb-15-2020
29 Spacelabs Healthcare, Ltd. I Aug-10-2018
30 Ventec Life Systems, Inc. II Jun-21-2021
31 Vyaire Medical I Feb-16-2022
32 Vyaire Medical II Mar-04-2020
33 ZOLL Medical Corporation II Mar-01-2018
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