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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
Product CodeMNT
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2878 2878
2018 2202 2202
2019 9350 9350
2020 4170 4170
2021 3791 3791
2022 2015 2015

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 2434 2434
Defective Component 1954 1954
Inadequate User Interface 1888 1888
Therapeutic or Diagnostic Output Failure 1447 1447
Incorrect, Inadequate or Imprecise Resultor Readings 1439 1439
Defective Device 1265 1265
Battery Problem 1156 1156
Device Alarm System 1068 1068
Failure to Power Up 906 906
Output Problem 789 789
No Display/Image 699 699
Device Operates Differently Than Expected 588 588
Device Sensing Problem 534 534
Power Problem 527 527
Device Inoperable 476 476
Display or Visual Feedback Problem 465 465
Defective Alarm 436 436
Break 366 366
Loss of Power 346 346
Unexpected Shutdown 343 343
Noise, Audible 335 335
Failure to Calibrate 325 325
Failure to Read Input Signal 269 269
Pressure Problem 255 255
Temperature Problem 245 245
Protective Measures Problem 239 239
Nonstandard Device 237 237
Excessive Heating 234 234
Failure to Charge 233 233
Gas Leak 229 229
Calibration Problem 228 228
Mechanical Problem 217 217
Self-Activation or Keying 215 215
Appropriate Term/Code Not Available 197 197
Failure to Shut Off 187 187
Computer Operating System Problem 176 176
Failure of Device to Self-Test 140 140
Tidal Volume Fluctuations 134 134
No Flow 133 133
Electrical /Electronic Property Problem 132 132
Leak/Splash 127 127
Poor Quality Image 123 123
Operating System Becomes Nonfunctional 101 101
Infusion or Flow Problem 101 101
Crack 88 88
Overheating of Device 83 83
Insufficient Information 82 82
Improper Flow or Infusion 80 80
Insufficient Flow or Under Infusion 79 79
Image Display Error/Artifact 79 79
Application Program Freezes, Becomes Nonfunctional 77 77
Key or Button Unresponsive/not Working 75 75
Increase in Pressure 75 75
Adverse Event Without Identified Device or Use Problem 72 72
Charging Problem 71 71
Energy Output Problem 70 70
Failure to Sense 67 67
Inaccurate Flow Rate 66 66
Gas Output Problem 61 61
Unintended Power Up 61 61
Display Difficult to Read 60 60
Volume Accuracy Problem 60 60
Failure to Deliver 60 60
Disconnection 59 59
No Audible Alarm 58 58
Application Interface Becomes Non-Functional Or Program Exits Abnormally 57 57
Failure to Align 57 57
Intermittent Loss of Power 57 57
Vibration 53 53
Failure to Run on Battery 53 53
Obstruction of Flow 52 52
Component Missing 51 51
Device Stops Intermittently 51 51
Degraded 50 50
Use of Device Problem 47 47
Device Emits Odor 46 46
No Device Output 45 45
Failure to Zero 44 44
Circuit Failure 43 43
Audible Prompt/Feedback Problem 43 43
Mechanical Jam 41 41
Computer Software Problem 41 41
Loose or Intermittent Connection 41 41
Connection Problem 38 38
Detachment of Device or Device Component 38 38
No Audible Prompt/Feedback 34 34
Communication or Transmission Problem 33 33
Application Program Problem 33 33
Material Integrity Problem 31 31
Decrease in Pressure 31 31
Erratic or Intermittent Display 31 31
Failure To Run On AC/DC 30 30
Inaccurate Delivery 30 30
Intermittent Energy Output 29 29
Incorrect Or Inadequate Test Results 27 27
Use of Incorrect Control Settings 27 27
Intermittent Continuity 25 25
Inappropriate or Unexpected Reset 25 25
Complete Loss of Power 25 25
Unable to Obtain Readings 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 9805 9805
No Clinical Signs, Symptoms or Conditions 6754 6754
No Known Impact Or Consequence To Patient 5284 5284
No Consequences Or Impact To Patient 1787 1787
Insufficient Information 520 520
Low Oxygen Saturation 97 97
Death 89 89
Hypoxia 72 72
No Information 38 38
Dyspnea 17 17
Respiratory Distress 14 14
Cardiac Arrest 11 11
Cardiopulmonary Arrest 9 9
No Code Available 9 9
Injury 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Bradycardia 7 7
Respiratory Failure 6 6
Respiratory Arrest 5 5
Loss of consciousness 4 4
Pressure Sores 4 4
Bacterial Infection 4 4
Pain 4 4
Cyanosis 3 3
Fall 3 3
Discomfort 3 3
Patient Problem/Medical Problem 3 3
Aspiration Pneumonitis 3 3
Hypoventilation 2 2
Asystole 2 2
Increased Respiratory Rate 2 2
Lethargy 2 2
Abdominal Distention 2 2
Complaint, Ill-Defined 2 2
Ventilator Dependent 2 2
Pulmonary Emphysema 2 2
Apnea 2 2
Chest Pain 2 2
Fainting 2 2
Tachycardia 2 2
Tissue Damage 2 2
Pneumonia 2 2
Pneumothorax 1 1
Renal Failure 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Urinary Retention 1 1
Vomiting 1 1
Septic Shock 1 1
Bruise/Contusion 1 1
Abnormal Blood Gases 1 1
Adult Respiratory Distress Syndrome 1 1
Encephalopathy 1 1
Asphyxia 1 1
Flatus 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Coma 1 1
Diabetic Ketoacidosis 1 1
Fungal Infection 1 1
Sweating 1 1
Chest Tightness/Pressure 1 1
Distress 1 1
Hypoxia in Utero 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Response, Decreased 1 1
Respiratory Acidosis 1 1
Cognitive Changes 1 1
Hematuria 1 1
Cardiovascular Insufficiency 1 1
Heart Failure/Congestive Heart Failure 1 1
Foreign Body In Patient 1 1
Respiratory Insufficiency 1 1
Wheezing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips Respironics, Inc. II May-21-2021
2 ResMed Ltd. I Feb-07-2020
3 Respironics California Inc I May-18-2017
4 Respironics California Inc II Mar-27-2017
5 Respironics California, LLC I Apr-18-2022
6 Respironics California, LLC I Feb-25-2022
7 Respironics California, LLC I Jul-22-2021
8 Respironics California, LLC II Feb-19-2021
9 Respironics California, LLC II Jan-22-2021
10 Respironics California, LLC II Jan-22-2021
11 Respironics California, LLC II Mar-31-2020
12 Respironics California, LLC II Mar-02-2020
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