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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
Regulation Description Continuous ventilator.
Product CodeMNS
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BMC MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BREAS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
SMD MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 64 64
2021 254 254
2022 2499 2499
2023 1320 1320
2024 1562 1562
2025 1172 1172

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 5933 5933
Corroded 233 233
Contamination 227 227
Electrical /Electronic Property Problem 176 176
Adverse Event Without Identified Device or Use Problem 172 172
Circuit Failure 76 76
Unexpected Shutdown 61 61
Nonstandard Device 46 46
Failure to Power Up 24 24
Power Problem 21 21
Patient-Device Incompatibility 20 20
Contamination /Decontamination Problem 20 20
Device Emits Odor 19 19
Device Sensing Problem 19 19
Insufficient Information 19 19
Battery Problem 17 17
Material Integrity Problem 13 13
Mechanical Problem 12 12
Pressure Problem 10 10
Noise, Audible 9 9
No Display/Image 9 9
Device Displays Incorrect Message 9 9
Increase in Pressure 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Alarm System 7 7
No Apparent Adverse Event 6 6
Overheating of Device 6 6
Failure to Charge 5 5
Decrease in Pressure 5 5
Break 5 5
Fire 5 5
Defective Alarm 5 5
Defective Component 5 5
Defective Device 5 5
Device Contamination with Chemical or Other Material 4 4
Patient Device Interaction Problem 4 4
Excessive Heating 4 4
Complete Loss of Power 4 4
No Audible Alarm 3 3
Computer Software Problem 3 3
Smoking 3 3
Material Disintegration 3 3
Self-Activation or Keying 3 3
Failure to Run on Battery 3 3
Temperature Problem 3 3
Leak/Splash 3 3
Protective Measures Problem 2 2
Failure to Calibrate 2 2
Inaccurate Delivery 2 2
Display or Visual Feedback Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4192 4192
Unspecified Respiratory Problem 750 750
Headache 632 632
Dyspnea 600 600
Cancer 413 413
Dizziness 398 398
Cough 255 255
Sore Throat 242 242
Asthma 232 232
Insufficient Information 223 223
Respiratory Tract Infection 215 215
Unspecified Kidney or Urinary Problem 214 214
Nausea 150 150
Skin Inflammation/ Irritation 149 149
Inflammation 145 145
Unspecified Heart Problem 120 120
Vomiting 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 105 105
Hypersensitivity/Allergic reaction 99 99
Unspecified Hepatic or Biliary Problem 73 73
Dry Mouth 72 72
Chronic Obstructive Pulmonary Disease (COPD) 60 60
Chest Pain 55 55
Sleep Dysfunction 47 47
Heart Failure/Congestive Heart Failure 46 46
Pneumonia 38 38
Pulmonary Dysfunction 38 38
Epistaxis 37 37
Stroke/CVA 35 35
Liver Damage/Dysfunction 33 33
Fatigue 31 31
Nodule 26 26
No Patient Involvement 25 25
Apnea 23 23
Bronchitis 20 20
Atrial Fibrillation 19 19
Respiratory Failure 19 19
Pharyngitis 17 17
Low Oxygen Saturation 16 16
Pain 16 16
Cardiovascular Insufficiency 15 15
Dry Eye(s) 15 15
Cardiac Arrest 15 15
Unspecified Eye / Vision Problem 15 15
Renal Failure 14 14
Sneezing 14 14
Unspecified Infection 14 14
Myocardial Infarction 14 14
Unspecified Gastrointestinal Problem 14 14
High Blood Pressure/ Hypertension 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Philips Respironics, Inc. I Jul-02-2025
2 Philips Respironics, Inc. I May-24-2024
3 Philips Respironics, Inc. I May-23-2024
4 Philips Respironics, Inc. I Sep-09-2022
5 Philips Respironics, Inc. I Jul-15-2021
6 Philips Respironics, Inc. I Jul-13-2021
7 Philips Respironics, Inc. II May-21-2021
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