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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
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9350 9350
2020 4170 4170
2021 3790 3790
2022 3277 3277
2023 4567 4567
2024 1141 1141

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate User Interface 3166 3166
Defective Component 1864 1864
Therapeutic or Diagnostic Output Failure 1447 1447
Incorrect, Inadequate or Imprecise Result or Readings 1436 1436
Device Alarm System 1417 1417
Battery Problem 1253 1253
Device Sensing Problem 1202 1202
Defective Device 1148 1148
Failure to Power Up 809 809
Output Problem 773 773
Power Problem 769 769
Unexpected Shutdown 705 705
Device Displays Incorrect Message 633 633
No Display/Image 600 600
Defective Alarm 536 536
Display or Visual Feedback Problem 520 520
Electrical /Electronic Property Problem 507 507
Gas/Air Leak 461 461
Excessive Heating 412 412
Mechanical Problem 376 376
Noise, Audible 319 319
Break 306 306
Failure to Calibrate 293 293
Pressure Problem 289 289
Protective Measures Problem 239 239
Failure to Sense 235 235
Failure to Shut Off 204 204
Failure to Charge 197 197
Loss of Power 194 194
Self-Activation or Keying 191 191
Failure to Read Input Signal 189 189
Tidal Volume Fluctuations 189 189
Calibration Problem 179 179
Failure to Deliver 178 178
Unintended Power Up 172 172
Display Difficult to Read 165 165
Circuit Failure 164 164
Computer Operating System Problem 162 162
No Flow 160 160
Failure to Run on Battery 153 153
Infusion or Flow Problem 151 151
Appropriate Term/Code Not Available 138 138
Temperature Problem 137 137
Insufficient Flow or Under Infusion 127 127
Complete Loss of Power 120 120
Poor Quality Image 116 116
Improper Flow or Infusion 113 113
Volume Accuracy Problem 109 109
Increase in Pressure 102 102
Failure of Device to Self-Test 99 99
Insufficient Information 99 99
Leak/Splash 90 90
Obstruction of Flow 88 88
Operating System Becomes Nonfunctional 82 82
Crack 81 81
Image Display Error/Artifact 75 75
Key or Button Unresponsive/not Working 75 75
Inaccurate Flow Rate 74 74
Communication or Transmission Problem 71 71
Energy Output Problem 70 70
Gas Output Problem 67 67
Degraded 64 64
Adverse Event Without Identified Device or Use Problem 61 61
Application Program Freezes, Becomes Nonfunctional 61 61
No Audible Alarm 60 60
Overheating of Device 57 57
Intermittent Loss of Power 57 57
Computer Software Problem 54 54
Decrease in Pressure 53 53
Mechanical Jam 52 52
Charging Problem 50 50
Vibration 50 50
Failure to Align 49 49
Detachment of Device or Device Component 49 49
Material Integrity Problem 49 49
Disconnection 47 47
Erratic or Intermittent Display 46 46
Grounding Malfunction 44 44
Component Missing 43 43
Audible Prompt/Feedback Problem 43 43
Failure to Zero 41 41
No Device Output 41 41
Use of Device Problem 38 38
Device Emits Odor 37 37
Loose or Intermittent Connection 35 35
No Audible Prompt/Feedback 35 35
Inaccurate Delivery 29 29
Excess Flow or Over-Infusion 29 29
Intermittent Energy Output 29 29
Connection Problem 29 29
Application Program Problem 27 27
No Pressure 26 26
Blocked Connection 25 25
Use of Incorrect Control/Treatment Settings 25 25
Unable to Obtain Readings 24 24
Date/Time-Related Software Problem 23 23
Human-Device Interface Problem 23 23
Physical Resistance/Sticking 22 22
Unstable 19 19
Intermittent Continuity 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13649 13649
No Patient Involvement 7672 7672
No Known Impact Or Consequence To Patient 3030 3030
No Consequences Or Impact To Patient 1226 1226
Insufficient Information 553 553
Hypoxia 97 97
Low Oxygen Saturation 80 80
Death 46 46
Dyspnea 27 27
Unspecified Respiratory Problem 15 15
Cardiac Arrest 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Respiratory Arrest 8 8
No Information 6 6
Injury 6 6
Bradycardia 6 6
Respiratory Distress 5 5
Respiratory Failure 5 5
Pressure Sores 3 3
No Code Available 3 3
Discomfort 3 3
Respiratory Insufficiency 3 3
Pain 3 3
Bacterial Infection 3 3
Fall 3 3
Aspiration Pneumonitis 3 3
Pulmonary Emphysema 2 2
Apnea 2 2
Cardiopulmonary Arrest 2 2
Chest Pain 2 2
Cyanosis 2 2
Fainting 2 2
Hypoventilation 2 2
Pneumonia 2 2
Tachycardia 2 2
Tissue Damage 2 2
Asystole 2 2
Lethargy 2 2
Increased Respiratory Rate 2 2
Loss of consciousness 2 2
Fungal Infection 1 1
Respiratory Tract Infection 1 1
Obstruction/Occlusion 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Anxiety 1 1
Distress 1 1
Ventilator Dependent 1 1
Hypoxia in Utero 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Response, Decreased 1 1
Respiratory Acidosis 1 1
Cancer 1 1
Convulsion/Seizure 1 1
Cardiovascular Insufficiency 1 1
Heart Failure/Congestive Heart Failure 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Wheezing 1 1
Nodule 1 1
Urinary Retention 1 1
Vomiting 1 1
Pneumothorax 1 1
Renal Failure 1 1
Septic Shock 1 1
Pleural Effusion 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Congenital Defect/Deformity 1 1
Abnormal Blood Gases 1 1
Bruise/Contusion 1 1
Encephalopathy 1 1
Asphyxia 1 1
Hematoma 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DRE Medical Group Inc II Jun-29-2023
2 Philips Respironics, Inc. I Sep-28-2023
3 Philips Respironics, Inc. II May-21-2021
4 ResMed Ltd. I Feb-07-2020
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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