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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, minimal ventilatory support, facility use
Regulation Description Continuous ventilator.
Product CodeMNT
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1649 1649
2016 2516 2516
2017 2877 2877
2018 2201 2201
2019 9350 9350
2020 2984 2984

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 3758 3758
Screen 2189 2189
Device Operates Differently Than Expected 1697 1697
Defective Component 1578 1578
Incorrect, Inadequate or Imprecise Resultor Readings 1381 1381
Therapeutic or Diagnostic Output Failure 1250 1250
Defective Device 1207 1207
Ring 1160 1160
Device Inoperable 1004 1004
Device Alarm System 974 974
Failure to Power Up 945 945
Battery Problem 887 887
Output Problem 769 769
No Display/Image 729 729
LED (Light Emitting Diode) 633 633
Loss of Power 517 517
Battery 502 502
Inadequate User Interface 380 380
Break 376 376
Display or Visual Feedback Problem 366 366
Sensor 344 344
Failure to Calibrate 302 302
Temperature Problem 301 301
Power Problem 298 298
Failure to Charge 296 296
Calibration Problem 238 238
Nonstandard Device 227 227
Alarm, Audible 224 224
Failure to Read Input Signal 223 223
Protective Measures Problem 207 207
Defective Alarm 204 204
Noise, Audible 199 199
Self-Activation or Keying 190 190
Pressure Problem 188 188
Appropriate Term/Code Not Available 184 184
Computer Operating System Problem 184 184
Blower 181 181
Failure of Device to Self-Test 173 173
Leak/Splash 164 164
Display 162 162
Failure to Shut Off 156 156
Switch, Push Button 137 137
Data Acquisition Unit 136 136
Tidal Volume Fluctuations 131 131
Mechanical Problem 113 113
Pressure Sensor 111 111
Device Sensing Problem 110 110
Poor Quality Image 94 94
No Flow 94 94
Charging Problem 89 89
Operating System Becomes Nonfunctional 88 88
Gas Leak 82 82
Device Stops Intermittently 81 81
Unexpected Shutdown 81 81
Application Interface Becomes Non-Functional Or Program Exits Abnormally 80 80
Electrical /Electronic Property Problem 74 74
Overheating of Device 68 68
Energy Output Problem 66 66
Failure to Sense 66 66
Crack 66 66
Adverse Event Without Identified Device or Use Problem 66 66
Image Display Error/Artifact 65 65
Device Emits Odor 64 64
Unit 62 62
Application Program Freezes, Becomes Nonfunctional 62 62
Infusion or Flow Problem 59 59
PC (Printed Circuit) Board 58 58
Failure to Align 55 55
Failure To Run On AC/DC 54 54
Component Missing 52 52
Vibration 52 52
Disconnection 51 51
Inaccurate Flow Rate 50 50
No Audible Alarm 50 50
Data Problem 45 45
Improper Flow or Infusion 43 43
Use of Device Problem 42 42
Alarm, LED 41 41
Power Supply 41 41
Loose or Intermittent Connection 38 38
No Device Output 37 37
Connection Problem 37 37
Power Cord 37 37
Communication or Transmission Problem 36 36
Failure to Zero 36 36
Volume Accuracy Problem 35 35
Insufficient Information 35 35
Calibration Error 33 33
Indicator 32 32
Incorrect Or Inadequate Test Results 32 32
Application Program Problem 31 31
Increase in Pressure 31 31
Power Switch 31 31
Use of Incorrect Control Settings 31 31
Power Conditioning Problem 30 30
Smoking 29 29
Out-Of-Box Failure 29 29
Intermittent Continuity 28 28
Cover 27 27
Occlusion Within Device 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 12083 12083
No Known Impact Or Consequence To Patient 6275 6275
No Consequences Or Impact To Patient 2510 2510
No Clinical Signs, Symptoms or Conditions 342 342
Death 112 112
No Information 98 98
Low Oxygen Saturation 69 69
Insufficient Information 23 23
Respiratory Distress 20 20
No Code Available 16 16
Injury 8 8
Cardiopulmonary Arrest 8 8
Pressure Sores 6 6
Patient Problem/Medical Problem 6 6
Bradycardia 6 6
Dyspnea 5 5
Respiratory Failure 4 4
Hypoxia 4 4
Cardiac Arrest 3 3
Complaint, Ill-Defined 3 3
Brain Injury 2 2
Bruise/Contusion 2 2
Tissue Damage 2 2
Loss of consciousness 2 2
Abdominal Distention 2 2
Fainting 2 2
Hypoventilation 2 2
Burn(s) 1 1
Fall 1 1
Flatus 1 1
Pulmonary Emphysema 1 1
Cyanosis 1 1
Underdose 1 1
Hematuria 1 1
Coma 1 1
Respiratory Acidosis 1 1
Vomiting 1 1
Heart Failure 1 1
Tachycardia 1 1
Unspecified Infection 1 1
Pain 1 1
Pneumonia 1 1
Abnormal Blood Gases 1 1
Adult Respiratory Distress Syndrome 1 1
Bacterial Infection 1 1
Chest Pain 1 1
Asphyxia 1 1
Hemorrhage/Bleeding 1 1
Anxiety 1 1
Inadequate Osseointegration 1 1
Diabetic Ketoacidosis 1 1
Ventilator Dependent 1 1
Chest Tightness/Pressure 1 1
Increased Respiratory Rate 1 1
ST Segment Depression 1 1
Loss Of Pulse 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ResMed Ltd. I Feb-07-2020
2 Respironics California Inc I May-18-2017
3 Respironics California Inc II Mar-27-2017
4 Respironics California, LLC II Mar-31-2020
5 Respironics California, LLC II Mar-02-2020
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