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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
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2516 2516
2017 2878 2878
2018 2202 2202
2019 9350 9350
2020 4170 4170
2021 3298 3298

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 3335 3335
Defective Component 1959 1959
Therapeutic or Diagnostic Output Failure 1446 1446
Incorrect, Inadequate or Imprecise Resultor Readings 1436 1436
Defective Device 1275 1275
Device Operates Differently Than Expected 1229 1229
Inadequate User Interface 1223 1223
Battery Problem 1088 1088
Device Alarm System 1045 1045
Failure to Power Up 975 975
Device Inoperable 798 798
Output Problem 788 788
No Display/Image 786 786
Loss of Power 456 456
Power Problem 439 439
Display or Visual Feedback Problem 419 419
Break 402 402
Defective Alarm 392 392
Failure to Calibrate 342 342
Noise, Audible 308 308
Temperature Problem 300 300
Failure to Charge 298 298
Device Sensing Problem 292 292
Failure to Read Input Signal 278 278
Calibration Problem 245 245
Nonstandard Device 237 237
Protective Measures Problem 234 234
Pressure Problem 232 232
Self-Activation or Keying 225 225
Appropriate Term/Code Not Available 199 199
Unexpected Shutdown 197 197
Failure to Shut Off 186 186
Computer Operating System Problem 185 185
Mechanical Problem 182 182
Gas Leak 169 169
Failure of Device to Self-Test 164 164
Tidal Volume Fluctuations 149 149
Leak/Splash 146 146
Poor Quality Image 123 123
No Flow 118 118
Excessive Heating 109 109
Electrical /Electronic Property Problem 109 109
Operating System Becomes Nonfunctional 102 102
Charging Problem 89 89
Overheating of Device 86 86
Crack 83 83
Application Interface Becomes Non-Functional Or Program Exits Abnormally 79 79
Image Display Error/Artifact 78 78
Application Program Freezes, Becomes Nonfunctional 77 77
Adverse Event Without Identified Device or Use Problem 76 76
Key or Button Unresponsive/not Working 75 75
Failure to Sense 74 74
Device Stops Intermittently 71 71
Energy Output Problem 70 70
Infusion or Flow Problem 70 70
Improper Flow or Infusion 63 63
Disconnection 63 63
Insufficient Information 61 61
Failure to Align 60 60
No Audible Alarm 60 60
Inaccurate Flow Rate 60 60
Device Emits Odor 57 57
Gas Output Problem 55 55
Vibration 53 53
Component Missing 53 53
Insufficient Flow or Under Infusion 53 53
Increase in Pressure 52 52
Intermittent Loss of Power 52 52
Failure to Run on Battery 49 49
Use of Device Problem 49 49
Volume Accuracy Problem 46 46
Failure to Zero 46 46
No Device Output 46 46
Audible Prompt/Feedback Problem 43 43
Connection Problem 42 42
Failure To Run On AC/DC 42 42
Loose or Intermittent Connection 41 41
Obstruction of Flow 39 39
Computer Software Problem 37 37
Detachment of Device or Device Component 37 37
Communication or Transmission Problem 37 37
Application Program Problem 37 37
Data Problem 37 37
Failure to Deliver 35 35
Unintended Power Up 33 33
Incorrect Or Inadequate Test Results 32 32
Calibration Error 31 31
Intermittent Continuity 31 31
No Audible Prompt/Feedback 31 31
Inappropriate or Unexpected Reset 29 29
Intermittent Energy Output 29 29
Decrease in Pressure 28 28
Erratic or Intermittent Display 28 28
Use of Incorrect Control Settings 27 27
Circuit Failure 27 27
Power Conditioning Problem 27 27
Inaccurate Delivery 27 27
Smoking 26 26
Display Difficult to Read 26 26
Mechanical Jam 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 11237 11237
No Known Impact Or Consequence To Patient 5933 5933
No Clinical Signs, Symptoms or Conditions 4385 4385
No Consequences Or Impact To Patient 2178 2178
Insufficient Information 351 351
Death 108 108
Low Oxygen Saturation 99 99
No Information 46 46
Hypoxia 38 38
Respiratory Distress 19 19
No Code Available 11 11
Injury 9 9
Cardiopulmonary Arrest 9 9
Cardiac Arrest 8 8
Bradycardia 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Dyspnea 6 6
Pressure Sores 6 6
Pain 3 3
Patient Problem/Medical Problem 3 3
Loss of consciousness 3 3
Respiratory Failure 3 3
Increased Respiratory Rate 2 2
Abdominal Distention 2 2
Respiratory Arrest 2 2
Unspecified Respiratory Problem 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Tachycardia 2 2
Tissue Damage 2 2
Pulmonary Emphysema 2 2
Fainting 2 2
Fall 2 2
Bruise/Contusion 2 2
Hypoventilation 2 2
Chest Pain 2 2
Cyanosis 2 2
Adult Respiratory Distress Syndrome 1 1
Bacterial Infection 1 1
Asphyxia 1 1
Flatus 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Urinary Retention 1 1
Vomiting 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Distress 1 1
Pneumonia 1 1
Renal Failure 1 1
Heart Failure 1 1
Therapeutic Response, Decreased 1 1
Asystole 1 1
ST Segment Depression 1 1
Cognitive Changes 1 1
Hematuria 1 1
Lethargy 1 1
Respiratory Acidosis 1 1
Inadequate Osseointegration 1 1
Fungal Infection 1 1
Sweating 1 1
Chest Tightness/Pressure 1 1
Diabetic Ketoacidosis 1 1
Ventilator Dependent 1 1
Coma 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 Jul-22-2021
6 Respironics California, LLC II Feb-19-2021
7 Respironics California, LLC II Jan-22-2021
8 Respironics California, LLC II Jan-22-2021
9 Respironics California, LLC II Mar-31-2020
10 Respironics California, LLC II Mar-02-2020
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