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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
SMD MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 275 275
2020 64 64
2021 254 254
2022 2499 2499
2023 1313 1313
2024 224 224

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 3805 3805
Corroded 233 233
Contamination 71 71
Nonstandard Device 46 46
Device Displays Incorrect Message 42 42
Battery Problem 39 39
Failure to Power Up 34 34
Electrical /Electronic Property Problem 34 34
Adverse Event Without Identified Device or Use Problem 30 30
Unexpected Shutdown 28 28
Power Problem 26 26
Output Problem 26 26
Pressure Problem 24 24
Device Alarm System 23 23
Patient-Device Incompatibility 20 20
Therapeutic or Diagnostic Output Failure 20 20
Insufficient Information 19 19
Circuit Failure 18 18
Protective Measures Problem 17 17
Increase in Pressure 15 15
Device Emits Odor 14 14
Defective Component 13 13
Defective Device 11 11
Failure to Charge 11 11
Noise, Audible 11 11
Material Integrity Problem 10 10
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Self-Activation or Keying 9 9
Display or Visual Feedback Problem 9 9
Failure to Calibrate 9 9
Mechanical Problem 9 9
Overheating of Device 7 7
Decrease in Pressure 7 7
Loss of Power 6 6
Break 6 6
Defective Alarm 6 6
Crack 6 6
Fire 5 5
Component Missing 5 5
Temperature Problem 5 5
Inadequate User Interface 4 4
Contamination /Decontamination Problem 4 4
Communication or Transmission Problem 4 4
Computer Operating System Problem 4 4
Calibration Problem 4 4
Patient Device Interaction Problem 4 4
Computer Software Problem 4 4
Thermal Decomposition of Device 3 3
No Audible Alarm 3 3
Unintended Power Up 3 3
Melted 3 3
No Display/Image 3 3
Failure to Run on Battery 3 3
Complete Loss of Power 3 3
Excessive Heating 3 3
Failure to Shut Off 3 3
Device Contamination with Chemical or Other Material 3 3
Device Sensing Problem 3 3
No Pressure 3 3
Improper Flow or Infusion 3 3
Detachment of Device or Device Component 2 2
Charging Problem 2 2
Electrical Shorting 2 2
Unintended Application Program Shut Down 2 2
Appropriate Term/Code Not Available 2 2
Failure to Sense 2 2
Smoking 2 2
Tidal Volume Fluctuations 2 2
Inaccurate Delivery 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Moisture Damage 2 2
Material Fragmentation 2 2
Intermittent Continuity 2 2
Material Disintegration 2 2
Display Difficult to Read 1 1
Insufficient Cooling 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
Failure to Cycle 1 1
Decrease in Suction 1 1
Loss of or Failure to Bond 1 1
Dent in Material 1 1
Application Security Problem 1 1
Blocked Connection 1 1
Unstable 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Inaccurate Synchronization 1 1
Fungus in Device Environment 1 1
Material Separation 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1
Premature End-of-Life Indicator 1 1
Pacing Problem 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2656 2656
Dyspnea 553 553
Headache 370 370
Unspecified Respiratory Problem 294 294
Cough 237 237
Sore Throat 230 230
Respiratory Tract Infection 180 180
No Patient Involvement 176 176
Dizziness 152 152
Cancer 123 123
No Known Impact Or Consequence To Patient 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Dry Mouth 67 67
Insufficient Information 62 62
Nausea 58 58
Unspecified Heart Problem 57 57
No Consequences Or Impact To Patient 53 53
Chest Pain 47 47
Asthma 45 45
Sleep Dysfunction 40 40
Skin Inflammation/ Irritation 40 40
Epistaxis 35 35
Unspecified Kidney or Urinary Problem 32 32
Inflammation 28 28
Hypersensitivity/Allergic reaction 26 26
Stroke/CVA 26 26
Vomiting 26 26
Fatigue 25 25
Apnea 22 22
Pneumonia 20 20
Heart Failure/Congestive Heart Failure 20 20
Nodule 20 20
Chronic Obstructive Pulmonary Disease (COPD) 18 18
Pharyngitis 17 17
Pain 15 15
Cardiac Arrest 15 15
Dry Eye(s) 14 14
Unspecified Eye / Vision Problem 14 14
Unspecified Hepatic or Biliary Problem 13 13
Liver Damage/Dysfunction 13 13
Sneezing 13 13
Low Oxygen Saturation 12 12
Unspecified Infection 12 12
Atrial Fibrillation 12 12
Rash 11 11
Renal Failure 11 11
Swelling/ Edema 11 11
Unspecified Gastrointestinal Problem 10 10
Eye Pain 9 9
High Blood Pressure/ Hypertension 9 9
Bronchitis 9 9
Respiratory Failure 9 9
Burning Sensation 8 8
Angina 8 8
Pulmonary Dysfunction 8 8
Renal Impairment 8 8
Unspecified Ear or Labyrinth Problem 7 7
Myocardial Infarction 7 7
Arrhythmia 7 7
Pulmonary Emphysema 7 7
Choking 7 7
Nasal Obstruction 6 6
Discomfort 6 6
Anxiety 6 6
Confusion/ Disorientation 6 6
Lethargy 6 6
Memory Loss/Impairment 6 6
Hemoptysis 6 6
Fever 5 5
Death 5 5
Abdominal Pain 5 5
Weight Changes 5 5
Respiratory Insufficiency 5 5
Wheezing 5 5
Skin Disorders 5 5
Solid Tumour 4 4
Pulmonary Hypertension 4 4
Eye Infections 4 4
Cognitive Changes 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Malaise 4 4
Bacterial Infection 4 4
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Red Eye(s) 4 4
Breast Cancer 3 3
Overinflation of Lung 3 3
Loss of Vision 3 3
Tachycardia 3 3
Tinnitus 3 3
Balance Problems 3 3
Convulsion/Seizure 2 2
Unspecified Blood or Lymphatic problem 2 2
Syncope/Fainting 2 2
Eye Burn 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 2 2
Chemical Exposure 2 2
Numbness 2 2
Fungal Infection 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
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