• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
  1.  K191624  F&P Nivairo RT047 Vented Hospital Full Face Mask, ...

MDR Year MDR Reports MDR Events
2015 1649 1649
2016 2516 2516
2017 2877 2877
2018 2201 2201
2019 9350 9350
2020 3229 3229

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 3772 3772
Screen 2189 2189
Device Operates Differently Than Expected 1697 1697
Defective Component 1634 1634
Incorrect, Inadequate or Imprecise Resultor Readings 1385 1385
Therapeutic or Diagnostic Output Failure 1275 1275
Defective Device 1215 1215
Ring 1160 1160
Device Inoperable 1004 1004
Device Alarm System 982 982
Failure to Power Up 951 951
Battery Problem 906 906
Output Problem 771 771
No Display/Image 739 739
LED (Light Emitting Diode) 633 633
Loss of Power 517 517
Battery 502 502
Inadequate User Interface 380 380
Break 378 378
Display or Visual Feedback Problem 369 369
Sensor 344 344
Failure to Calibrate 304 304
Temperature Problem 304 304
Failure to Charge 303 303
Power Problem 300 300
Calibration Problem 239 239
Nonstandard Device 228 228
Failure to Read Input Signal 227 227
Alarm, Audible 224 224
Defective Alarm 217 217
Protective Measures Problem 207 207
Noise, Audible 203 203
Self-Activation or Keying 194 194
Pressure Problem 190 190
Appropriate Term/Code Not Available 187 187
Computer Operating System Problem 185 185
Blower 181 181
Failure of Device to Self-Test 176 176
Leak/Splash 165 165
Display 162 162
Failure to Shut Off 158 158
Switch, Push Button 137 137
Data Acquisition Unit 136 136
Tidal Volume Fluctuations 133 133
Mechanical Problem 121 121
Device Sensing Problem 114 114
Pressure Sensor 111 111
Poor Quality Image 97 97
No Flow 95 95
Operating System Becomes Nonfunctional 91 91
Gas Leak 91 91
Charging Problem 90 90
Unexpected Shutdown 85 85
Device Stops Intermittently 81 81
Application Interface Becomes Non-Functional Or Program Exits Abnormally 80 80
Electrical /Electronic Property Problem 74 74
Overheating of Device 69 69
Energy Output Problem 67 67
Crack 67 67
Image Display Error/Artifact 66 66
Failure to Sense 66 66
Adverse Event Without Identified Device or Use Problem 66 66
Application Program Freezes, Becomes Nonfunctional 65 65
Device Emits Odor 64 64
Unit 62 62
Infusion or Flow Problem 59 59
PC (Printed Circuit) Board 58 58
Failure to Align 56 56
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 39 39
No Device Output 39 39
Failure to Zero 37 37
Connection Problem 37 37
Power Cord 37 37
Communication or Transmission Problem 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 12104 12104
No Known Impact Or Consequence To Patient 6279 6279
No Consequences Or Impact To Patient 2514 2514
No Clinical Signs, Symptoms or Conditions 540 540
Death 112 112
No Information 99 99
Low Oxygen Saturation 70 70
Insufficient Information 38 38
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
Respiratory Arrest 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
-
-