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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
  1.  K230173  Servo-air Lite Ventilator System
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 1776 1776

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate User Interface 3289 3289
Defective Component 1864 1864
Device Alarm System 1462 1462
Therapeutic or Diagnostic Output Failure 1447 1447
Incorrect, Inadequate or Imprecise Result or Readings 1437 1437
Battery Problem 1256 1256
Device Sensing Problem 1249 1249
Defective Device 1148 1148
Failure to Power Up 821 821
Power Problem 777 777
Output Problem 773 773
Unexpected Shutdown 732 732
Device Displays Incorrect Message 633 633
No Display/Image 621 621
Defective Alarm 541 541
Electrical /Electronic Property Problem 540 540
Display or Visual Feedback Problem 522 522
Gas/Air Leak 482 482
Excessive Heating 428 428
Mechanical Problem 400 400
Noise, Audible 319 319
Break 306 306
Failure to Calibrate 293 293
Pressure Problem 289 289
Failure to Sense 282 282
Protective Measures Problem 242 242
Failure to Charge 210 210
Failure to Shut Off 207 207
Tidal Volume Fluctuations 203 203
Failure to Run on Battery 197 197
Loss of Power 194 194
Failure to Deliver 194 194
Self-Activation or Keying 191 191
Failure to Read Input Signal 189 189
Calibration Problem 179 179
Unintended Power Up 176 176
Display Difficult to Read 175 175
Circuit Failure 170 170
Computer Operating System Problem 162 162
No Flow 160 160
Complete Loss of Power 152 152
Infusion or Flow Problem 151 151
Appropriate Term/Code Not Available 138 138
Temperature Problem 137 137
Insufficient Flow or Under Infusion 129 129
Poor Quality Image 116 116
Improper Flow or Infusion 113 113
Volume Accuracy Problem 109 109
Increase in Pressure 107 107
Insufficient Information 101 101
Failure of Device to Self-Test 99 99
Obstruction of Flow 93 93
Leak/Splash 90 90
Operating System Becomes Nonfunctional 82 82
Crack 81 81
Communication or Transmission Problem 78 78
Key or Button Unresponsive/not Working 75 75
Image Display Error/Artifact 75 75
Inaccurate Flow Rate 74 74
Energy Output Problem 70 70
Gas Output Problem 67 67
Degraded 64 64
Adverse Event Without Identified Device or Use Problem 62 62
Application Program Freezes, Becomes Nonfunctional 61 61
Computer Software Problem 61 61
Grounding Malfunction 61 61
No Audible Alarm 60 60
Intermittent Loss of Power 58 58
Overheating of Device 57 57
Decrease in Pressure 54 54
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
Erratic or Intermittent Display 48 48
Disconnection 47 47
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
Unstable 30 30
Inaccurate Delivery 30 30
Excess Flow or Over-Infusion 30 30
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
Device Contamination with Chemical or Other Material 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14271 14271
No Patient Involvement 7672 7672
No Known Impact Or Consequence To Patient 3030 3030
No Consequences Or Impact To Patient 1226 1226
Insufficient Information 557 557
Hypoxia 100 100
Low Oxygen Saturation 84 84
Death 46 46
Dyspnea 28 28
Unspecified Respiratory Problem 16 16
Cardiac Arrest 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Respiratory Arrest 8 8
Respiratory Failure 7 7
Injury 6 6
No Information 6 6
Bradycardia 6 6
Respiratory Distress 5 5
Discomfort 5 5
Increased Respiratory Rate 4 4
Pressure Sores 3 3
Respiratory Acidosis 3 3
No Code Available 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
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
Cancer 1 1
Convulsion/Seizure 1 1
Unspecified Vascular Problem 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 May-24-2024
3 Philips Respironics, Inc. I Sep-28-2023
4 Philips Respironics, Inc. II May-21-2021
5 ResMed Ltd. I Feb-07-2020
6 Respironics California, LLC I Apr-18-2022
7 Respironics California, LLC I Feb-25-2022
8 Respironics California, LLC I Jul-22-2021
9 Respironics California, LLC II Feb-19-2021
10 Respironics California, LLC II Jan-22-2021
11 Respironics California, LLC II Jan-22-2021
12 Respironics California, LLC II Mar-31-2020
13 Respironics California, LLC II Mar-02-2020
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