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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, non-life-supporting
Product CodeMNS
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BMC MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS RESPIRONICS, INC
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 3
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 10
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SMD MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
SMD MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 50 50
2016 16 16
2017 20 20
2018 22 22
2019 275 275
2020 64 64
2021 254 254
2022 2499 2499
2023 1314 1314
2024 326 326

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 3900 3900
Corroded 233 233
Contamination 72 72
Device Displays Incorrect Message 65 65
Nonstandard Device 46 46
Battery Problem 42 42
Adverse Event Without Identified Device or Use Problem 42 42
Device Alarm System 40 40
Failure to Power Up 38 38
Electrical /Electronic Property Problem 34 34
Power Problem 28 28
Unexpected Shutdown 28 28
Pressure Problem 26 26
Output Problem 26 26
Insufficient Information 22 22
Patient-Device Incompatibility 21 21
Therapeutic or Diagnostic Output Failure 20 20
Circuit Failure 19 19
Increase in Pressure 19 19
Protective Measures Problem 17 17
Defective Component 15 15
Device Emits Odor 14 14
Device Operates Differently Than Expected 14 14
Noise, Audible 13 13
Loss of Power 13 13
No Audible Alarm 13 13
Failure to Charge 12 12
Defective Device 12 12
Material Integrity Problem 10 10
Mechanical Problem 10 10
Display or Visual Feedback Problem 10 10
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Self-Activation or Keying 10 10
Overheating of Device 9 9
Break 9 9
Failure to Calibrate 9 9
Decrease in Pressure 8 8
Defective Alarm 7 7
No Flow 7 7
Crack 6 6
No Display/Image 5 5
Fire 5 5
Component Missing 5 5
Device Inoperable 5 5
Temperature Problem 5 5
Computer Operating System Problem 5 5
Calibration Problem 4 4
Contamination /Decontamination Problem 4 4
Communication or Transmission Problem 4 4
Inadequate User Interface 4 4
Patient Device Interaction Problem 4 4
Smoking 4 4
Thermal Decomposition of Device 4 4
Computer Software Problem 4 4
Failure to Cycle 3 3
Unintended Power Up 3 3
Melted 3 3
Inaccurate Delivery 3 3
Failure to Run on Battery 3 3
Complete Loss of Power 3 3
Excessive Heating 3 3
No Pressure 3 3
Device Sensing Problem 3 3
Detachment of Device or Device Component 3 3
Improper Flow or Infusion 3 3
Failure to Shut Off 3 3
Device Contamination with Chemical or Other Material 3 3
Electrical Power Problem 2 2
Electrical Shorting 2 2
Charging Problem 2 2
Device Operational Issue 2 2
Low Battery 2 2
Appropriate Term/Code Not Available 2 2
Unintended Application Program Shut Down 2 2
No Device Output 2 2
Failure to Sense 2 2
Tidal Volume Fluctuations 2 2
Device Stops Intermittently 2 2
Unstable 2 2
Moisture Damage 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Material Fragmentation 2 2
Intermittent Continuity 2 2
Material Disintegration 2 2
Display Difficult to Read 1 1
Insufficient Cooling 1 1
Material Frayed 1 1
Insufficient Heating 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 1
Poor Quality Image 1 1
Disconnection 1 1
Failure to Disinfect 1 1
Decrease in Suction 1 1
Loss of or Failure to Bond 1 1
Use of Device Problem 1 1
Vibration 1 1
Fitting Problem 1 1
Inaccurate Synchronization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2673 2673
Dyspnea 560 560
Headache 388 388
Unspecified Respiratory Problem 330 330
Cough 238 238
Sore Throat 231 231
No Patient Involvement 198 198
Respiratory Tract Infection 183 183
Dizziness 168 168
Cancer 153 153
No Known Impact Or Consequence To Patient 105 105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
No Consequences Or Impact To Patient 70 70
Asthma 70 70
Dry Mouth 67 67
Insufficient Information 64 64
Unspecified Heart Problem 61 61
Nausea 61 61
Unspecified Kidney or Urinary Problem 52 52
Chest Pain 48 48
Skin Inflammation/ Irritation 45 45
Sleep Dysfunction 42 42
Hypersensitivity/Allergic reaction 36 36
Epistaxis 35 35
Inflammation 33 33
Stroke/CVA 29 29
Vomiting 28 28
Fatigue 27 27
Chronic Obstructive Pulmonary Disease (COPD) 26 26
Heart Failure/Congestive Heart Failure 24 24
No Information 22 22
Pneumonia 22 22
Apnea 22 22
Nodule 21 21
Death 17 17
Pharyngitis 17 17
Pain 16 16
Low Oxygen Saturation 16 16
Cardiac Arrest 16 16
Liver Damage/Dysfunction 16 16
Unspecified Hepatic or Biliary Problem 15 15
Unspecified Eye / Vision Problem 15 15
Dry Eye(s) 14 14
Atrial Fibrillation 13 13
Sneezing 13 13
Renal Failure 12 12
Unspecified Infection 12 12
Rash 12 12
Bronchitis 11 11
Respiratory Failure 11 11
Swelling/ Edema 11 11
Unspecified Gastrointestinal Problem 10 10
Pulmonary Dysfunction 10 10
High Blood Pressure/ Hypertension 9 9
Renal Impairment 9 9
Eye Pain 9 9
Angina 8 8
Burning Sensation 8 8
Choking 7 7
Arrhythmia 7 7
Pulmonary Emphysema 7 7
Myocardial Infarction 7 7
Unspecified Ear or Labyrinth Problem 7 7
Solid Tumour 6 6
Memory Loss/Impairment 6 6
Hemoptysis 6 6
Abdominal Pain 6 6
Nasal Obstruction 6 6
Confusion/ Disorientation 6 6
Lethargy 6 6
Anxiety 6 6
Discomfort 6 6
Weight Changes 5 5
Fever 5 5
Skin Disorders 5 5
Respiratory Insufficiency 5 5
Wheezing 5 5
Pulmonary Hypertension 5 5
Unspecified Mental, Emotional or Behavioural Problem 4 4
Eye Infections 4 4
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Red Eye(s) 4 4
Bacterial Infection 4 4
Cognitive Changes 4 4
Patient Problem/Medical Problem 4 4
Malaise 4 4
Overinflation of Lung 3 3
Respiratory Distress 3 3
Loss of Vision 3 3
Tachycardia 3 3
Tinnitus 3 3
Balance Problems 3 3
Breast Cancer 3 3
Bradycardia 2 2
Pulmonary Embolism 2 2
Aneurysm 2 2
Bruise/Contusion 2 2
Pneumothorax 2 2
Muscle Weakness 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Philips Respironics, Inc. I Sep-09-2022
2 Philips Respironics, Inc. I Jul-15-2021
3 Philips Respironics, Inc. I Jul-13-2021
4 Philips Respironics, Inc. II May-21-2021
5 Respironics California Inc I Jul-07-2009
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