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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
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2202 2202
2019 9350 9350
2020 4170 4170
2021 3791 3791
2022 3277 3277

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate User Interface 2187 2187
Defective Component 1915 1915
Therapeutic or Diagnostic Output Failure 1446 1446
Incorrect, Inadequate or Imprecise Result or Readings 1440 1440
Defective Device 1259 1259
Battery Problem 1149 1149
Device Alarm System 1083 1083
Device Displays Incorrect Message 993 993
Failure to Power Up 792 792
Output Problem 791 791
Device Sensing Problem 661 661
No Display/Image 585 585
Power Problem 581 581
Display or Visual Feedback Problem 490 490
Defective Alarm 440 440
Unexpected Shutdown 418 418
Break 341 341
Noise, Audible 327 327
Failure to Calibrate 313 313
Excessive Heating 282 282
Pressure Problem 276 276
Gas/Air Leak 276 276
Mechanical Problem 254 254
Loss of Power 247 247
Failure to Read Input Signal 246 246
Protective Measures Problem 244 244
Calibration Problem 206 206
Self-Activation or Keying 202 202
Temperature Problem 201 201
Appropriate Term/Code Not Available 197 197
Failure to Charge 189 189
Failure to Shut Off 188 188
Computer Operating System Problem 173 173
Electrical /Electronic Property Problem 152 152
No Flow 133 133
Failure of Device to Self-Test 126 126
Infusion or Flow Problem 124 124
Tidal Volume Fluctuations 123 123
Device Operates Differently Than Expected 122 122
Poor Quality Image 116 116
Operating System Becomes Nonfunctional 98 98
Leak/Splash 96 96
Insufficient Flow or Under Infusion 92 92
Crack 88 88
Improper Flow or Infusion 87 87
Unintended Power Up 83 83
Insufficient Information 80 80
Application Program Freezes, Becomes Nonfunctional 78 78
Device Inoperable 77 77
Increase in Pressure 77 77
Image Display Error/Artifact 76 76
Display Difficult to Read 76 76
Key or Button Unresponsive/not Working 75 75
Failure to Deliver 74 74
Volume Accuracy Problem 71 71
Energy Output Problem 70 70
Inaccurate Flow Rate 69 69
Overheating of Device 68 68
Gas Output Problem 66 66
Failure to Sense 64 64
Adverse Event Without Identified Device or Use Problem 64 64
Charging Problem 64 64
Obstruction of Flow 61 61
Intermittent Loss of Power 60 60
Disconnection 55 55
No Audible Alarm 54 54
Failure to Run on Battery 54 54
Degraded 53 53
Failure to Align 52 52
Circuit Failure 51 51
Vibration 51 51
Component Missing 48 48
No Device Output 45 45
Use of Device Problem 43 43
Audible Prompt/Feedback Problem 43 43
Detachment of Device or Device Component 41 41
Failure to Zero 41 41
Computer Software Problem 41 41
Loose or Intermittent Connection 40 40
Material Integrity Problem 40 40
Mechanical Jam 40 40
Device Emits Odor 37 37
Decrease in Pressure 37 37
No Audible Prompt/Feedback 35 35
Erratic or Intermittent Display 32 32
Connection Problem 32 32
Application Program Problem 31 31
Inaccurate Delivery 30 30
Intermittent Energy Output 29 29
Complete Loss of Power 28 28
Use of Incorrect Control/Treatment Settings 27 27
Unable to Obtain Readings 24 24
Human-Device Interface Problem 24 24
Inappropriate or Unexpected Reset 23 23
Blocked Connection 23 23
Communication or Transmission Problem 23 23
No Pressure 23 23
Nonstandard Device 23 23
Physical Resistance/Sticking 22 22
Electrical Power Problem 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 8521 8521
No Clinical Signs, Symptoms or Conditions 8004 8004
No Known Impact Or Consequence To Patient 4122 4122
No Consequences Or Impact To Patient 1427 1427
Insufficient Information 524 524
Low Oxygen Saturation 90 90
Hypoxia 82 82
Death 75 75
Dyspnea 19 19
No Information 11 11
Cardiac Arrest 11 11
Unspecified Respiratory Problem 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Code Available 7 7
Respiratory Distress 7 7
Injury 6 6
Cardiopulmonary Arrest 6 6
Bradycardia 6 6
Respiratory Arrest 6 6
Respiratory Failure 6 6
Pressure Sores 4 4
Pain 4 4
Pneumonia 3 3
Discomfort 3 3
Aspiration Pneumonitis 3 3
Loss of consciousness 3 3
Fall 3 3
Bacterial Infection 3 3
Patient Problem/Medical Problem 2 2
Apnea 2 2
Tissue Damage 2 2
Asystole 2 2
Increased Respiratory Rate 2 2
Pulmonary Emphysema 2 2
Cyanosis 2 2
Lethargy 2 2
Fainting 2 2
Chest Pain 2 2
Tachycardia 2 2
Vomiting 1 1
Distress 1 1
Pleural Effusion 1 1
Adult Respiratory Distress Syndrome 1 1
Pneumothorax 1 1
Ventilator Dependent 1 1
High Blood Pressure/ Hypertension 1 1
Infiltration into Tissue 1 1
Encephalopathy 1 1
Fungal Infection 1 1
Sweating 1 1
Cognitive Changes 1 1
Hypoxia in Utero 1 1
Heart Failure/Congestive Heart Failure 1 1
Congenital Defect/Deformity 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Renal Failure 1 1
Septic Shock 1 1
Wheezing 1 1
Respiratory Acidosis 1 1
Foreign Body In Patient 1 1
Asphyxia 1 1
Cardiovascular Insufficiency 1 1
Urinary Retention 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Response, Decreased 1 1
Respiratory Tract Infection 1 1
Abnormal Blood Gases 1 1
Bruise/Contusion 1 1
Respiratory Insufficiency 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, LLC I Apr-18-2022
4 Respironics California, LLC I Feb-25-2022
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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