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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 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
Nonstandard Device 46 46
Device Displays Incorrect Message 42 42
Battery Problem 39 39
Adverse Event Without Identified Device or Use Problem 36 36
Failure to Power Up 35 35
Electrical /Electronic Property Problem 34 34
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 19 19
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 2673 2673
Dyspnea 559 559
Headache 388 388
Unspecified Respiratory Problem 330 330
Cough 238 238
Sore Throat 231 231
Respiratory Tract Infection 183 183
No Patient Involvement 176 176
Dizziness 168 168
Cancer 153 153
No Known Impact Or Consequence To Patient 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Asthma 69 69
Dry Mouth 67 67
Insufficient Information 64 64
Unspecified Heart Problem 61 61
Nausea 61 61
No Consequences Or Impact To Patient 53 53
Unspecified Kidney or Urinary Problem 52 52
Chest Pain 48 48
Skin Inflammation/ Irritation 45 45
Sleep Dysfunction 41 41
Hypersensitivity/Allergic reaction 35 35
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
Pneumonia 22 22
Apnea 22 22
Nodule 21 21
Pharyngitis 17 17
Pain 16 16
Liver Damage/Dysfunction 16 16
Cardiac Arrest 15 15
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
Low Oxygen Saturation 12 12
Unspecified Infection 12 12
Rash 12 12
Bronchitis 11 11
Swelling/ Edema 11 11
Unspecified Gastrointestinal Problem 10 10
Pulmonary Dysfunction 10 10
Respiratory Failure 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
Death 5 5
Fever 5 5
Skin Disorders 5 5
Pulmonary Hypertension 5 5
Respiratory Insufficiency 5 5
Wheezing 5 5
Eye Infections 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Red Eye(s) 4 4
Bacterial Infection 4 4
Cognitive Changes 4 4
Malaise 4 4
Overinflation of Lung 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
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Emotional Changes 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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