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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
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
SMD MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 20 20
2018 22 22
2019 275 275
2020 65 65
2021 246 246
2022 2355 2355

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 2491 2491
Device Displays Incorrect Message 54 54
Battery Problem 41 41
Nonstandard Device 33 33
Output Problem 26 26
Pressure Problem 25 25
Device Alarm System 23 23
Failure to Power Up 21 21
Therapeutic or Diagnostic Output Failure 20 20
Protective Measures Problem 17 17
Patient-Device Incompatibility 17 17
Adverse Event Without Identified Device or Use Problem 14 14
Power Problem 13 13
Unexpected Shutdown 13 13
Defective Component 13 13
Defective Device 11 11
Failure to Charge 11 11
Insufficient Information 11 11
Self-Activation or Keying 10 10
Increase in Pressure 10 10
Failure to Calibrate 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Display or Visual Feedback Problem 9 9
Loss of Power 8 8
Overheating of Device 7 7
Electrical /Electronic Property Problem 6 6
Break 6 6
Decrease in Pressure 6 6
Defective Alarm 5 5
Crack 5 5
Noise, Audible 5 5
Temperature Problem 4 4
Mechanical Problem 4 4
Device Emits Odor 4 4
Component Missing 4 4
Device Inoperable 4 4
Calibration Problem 4 4
Communication or Transmission Problem 4 4
Computer Operating System Problem 4 4
Device Operates Differently Than Expected 4 4
Melted 3 3
Thermal Decomposition of Device 3 3
Computer Software Problem 3 3
Fire 3 3
Improper Flow or Infusion 3 3
Inadequate User Interface 3 3
Failure to Shut Off 2 2
Device Contamination with Chemical or Other Material 2 2
Appropriate Term/Code Not Available 2 2
Unintended Application Program Shut Down 2 2
Material Fragmentation 2 2
Unintended Power Up 2 2
Contamination 2 2
Intermittent Continuity 2 2
No Audible Alarm 2 2
Failure to Cycle 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
No Display/Image 2 2
Failure to Run on Battery 2 2
Detachment of Device or Device Component 2 2
Device Sensing Problem 2 2
Charging Problem 2 2
Smoking 2 2
Device Stops Intermittently 1 1
Inaccurate Synchronization 1 1
Tidal Volume Fluctuations 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1
Unstable 1 1
Failure to Sense 1 1
Material Separation 1 1
Inaccurate Delivery 1 1
Low Battery 1 1
Blocked Connection 1 1
Application Security Problem 1 1
Device-Device Incompatibility 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Device Operational Issue 1 1
Premature End-of-Life Indicator 1 1
Pacing Problem 1 1
Particulates 1 1
Decrease in Suction 1 1
Moisture Damage 1 1
Poor Quality Image 1 1
Disconnection 1 1
Material Disintegration 1 1
Display Difficult to Read 1 1
Material Frayed 1 1
Image Display Error/Artifact 1 1
Key or Button Unresponsive/not Working 1 1
Data Problem 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Intermittent Loss of Power 1 1
Audible Prompt/Feedback Problem 1 1
Free or Unrestricted Flow 1 1
Human-Device Interface Problem 1 1
Inappropriate or Unexpected Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1844 1844
Dyspnea 232 232
No Patient Involvement 186 186
Headache 163 163
Sore Throat 121 121
Respiratory Tract Infection 114 114
Cough 107 107
No Known Impact Or Consequence To Patient 91 91
Unspecified Respiratory Problem 84 84
Cancer 74 74
Dizziness 61 61
No Consequences Or Impact To Patient 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Dry Mouth 29 29
Insufficient Information 28 28
Epistaxis 20 20
Nausea 19 19
Chest Pain 19 19
Asthma 14 14
Cardiac Arrest 14 14
Nodule 14 14
Unspecified Heart Problem 14 14
Heart Failure/Congestive Heart Failure 13 13
Stroke/CVA 13 13
Fatigue 13 13
Death 12 12
Low Oxygen Saturation 12 12
Skin Inflammation/ Irritation 11 11
Sleep Dysfunction 10 10
Apnea 10 10
Vomiting 10 10
Dry Eye(s) 9 9
Eye Pain 8 8
Unspecified Eye / Vision Problem 7 7
Unspecified Kidney or Urinary Problem 7 7
Hypersensitivity/Allergic reaction 7 7
Chronic Obstructive Pulmonary Disease (COPD) 7 7
Pain 7 7
Unspecified Infection 7 7
Inflammation 7 7
Sneezing 6 6
Discomfort 6 6
Angina 6 6
Renal Impairment 6 6
Swelling/ Edema 5 5
Unspecified Ear or Labyrinth Problem 5 5
Confusion/ Disorientation 5 5
Bronchitis 5 5
Rash 5 5
Liver Damage/Dysfunction 5 5
Pneumonia 5 5
Hemoptysis 4 4
Pulmonary Emphysema 4 4
Lethargy 4 4
Respiratory Failure 4 4
Patient Problem/Medical Problem 4 4
Respiratory Insufficiency 4 4
Wheezing 4 4
Pulmonary Hypertension 3 3
Eye Infections 3 3
Unspecified Hepatic or Biliary Problem 3 3
Solid Tumour 3 3
Weight Changes 3 3
Anxiety 3 3
Choking 3 3
Nasal Obstruction 3 3
Fever 3 3
Breast Cancer 3 3
Arrhythmia 3 3
Atrial Fibrillation 3 3
Loss of Vision 3 3
Burning Sensation 3 3
Memory Loss/Impairment 3 3
Renal Failure 3 3
Respiratory Distress 3 3
Hematoma 2 2
Pulmonary Dysfunction 2 2
Muscle Weakness 2 2
Myocardial Infarction 2 2
Malaise 2 2
Bacterial Infection 2 2
Emotional Changes 2 2
Hair Loss 2 2
High Blood Pressure/ Hypertension 2 2
Hypoventilation 2 2
Hypoxia 2 2
Fungal Infection 2 2
Eye Burn 2 2
Cognitive Changes 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
No Information 2 2
Balance Problems 2 2
Partial Hearing Loss 2 2
Unspecified Gastrointestinal Problem 1 1
Liver Failure 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Blister 1 1
Skin Disorders 1 1
Skin Infection 1 1
Syncope/Fainting 1 1

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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